What You Should Know:

– UltraSight – an AI-powered micro-ultrasound company that is revolutionizing cardiac sonography to enable more accurate and timely clinical decisions – is now offering its services to the Israel Defense Forces (IDF). The device has FDA clearance and is now available in Israel, the UK, and the US.

– Many of the IDF soldiers will now have an ultrasound in their pocket. The PoCUS devices – powered by UltraSight’s software – deliver fast diagnoses for those injured in combat. For example, if someone is experiencing shortness of breath, IDF soldiers can easily assess the situation in the field and then immediately triage.

– AI is bridging the expertise gap – enabling soldiers, who do not have prior sonography training, to obtain diagnostic quality cardiac images, and make quick, strategic decisions that could save lives.

What You Should Know:

GE HealthCare announced a $44M contract with the Biomedical Advanced Research and Development Authority (BARDA) —part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS)—to develop and obtain regulatory clearance for next-generation ultrasound technology with AI applications.

– The goal of the technology will support clinicians of all skill levels in efficiently diagnosing and providing treatment for patients with lung pathologies and traumatic injuries to the abdomen, chest, and head.

AI-Driven, Point-of-Care Ultrasound to Aid Emergency Situations

Trauma is a leading cause of death in the United States posing an enormous burden to healthcare systems and society. Trauma patients’ survival is dependent on receiving timely and appropriate care. Injury detection and triage of trauma patients play key roles in successful patient care and resource management, both in everyday situations and in mass casualty events. Technologies that expedite care, including detection, evaluation, and decision-assist capabilities, potentially increase patients’ chances of survival.

Through this collaboration with BARDA, GE Healthcare will build upon its existing point-of-care ultrasound technology portfolio to develop an advanced probe and ultrasound system together with novel AI technology to ease acquisition and interpretation of ultrasound exams for users of all skill levels. The proposed devices will cover indications for multiple injury types: blunt and penetrating trauma, head trauma, lung injuries, as well as multiple lung pathologies encountered outside trauma care such as those seen in infectious diseases.

“Point-of-care ultrasound is an essential tool in emergency situations to help clinicians quickly get the answers they need when treating patients,” said Roland Rott, President and CEO, Ultrasound, GE HealthCare. “We are grateful and excited for the opportunity to partner with BARDA to contribute our expertise in ultrasound and AI applications to develop innovative solutions for identifying a range of traumatic injuries and lung pathologies. Our collaboration has the potential to enhance the ability of clinicians to provide timely care for trauma patients even in the most dire scenarios.”

The project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00035.

Butterfly Network, Inc., a digital health company transforming care through the power of portable, semiconductor-based ultrasound technology and intuitive software, today announced the addition of two new ultrasound education offerings that will complete its full suite of education products. The new offerings will include:

– Butterfly Certified™, a complete set of virtual and in-person POCUS courses designed to meet local training or privileging requirements, delivered in partnership with the Global Ultrasound Institute (GUSI). The hands-on training packages are expert-led and include tailored tracks across specialties that can be scaled for individual or department use. Now available in the United States through direct Butterfly sales representatives.

– ScanLab™, an artificial intelligence (AI)-powered educational application for ultrasound scanning practice. The standalone app provides written walkthroughs and reference imagery to guide real-time educational scanning. Enhancing the learning process are AI image quality indicators that provide real-time feedback for image adjustment and interactive AI labeling to help learners locate key anatomy. Stay tuned for updates on release dates in the United States.

What You Should Know:

• Exo (pronounced “echo”), a medical imaging software and device company, today unveiled a category-redefining handheld ultrasound device, Exo Iris™, to put high-performance medical imaging into the hands—and pockets—of every caregiver.
• Built on Exo’s advanced silicon technology, Exo Iris delivers versatile imaging performance for point-of-care ultrasound (POCUS) at a fraction of the size and cost of cart-based systems. Exo Iris is the latest addition to Exo’s ecosystem, which combines imaging, workflow software, and artificial intelligence (AI) to enable POCUS adoption at a systems-wide scale to create new patient care pathways. Exo Iris gives caregivers—including physicians, nurses, EMTs, and clinicians in emergency, acute care, outpatient, and at-home settings—a window into the human body for immediate answers at the point of care.

Increasing Access to High-Quality Medical Imaging at Low Costs

“Exo Iris represents a new era of ultrasound,” said Sandeep Akkaraju, CEO and Co-Founder of Exo. “It’s built to perform as easily as taking an image with a smartphone. For caregivers who’ve bemoaned out-of-touch medical technology, you’ve been heard. This device is meant for you and everyone in healthcare—it will save lives, improve patient care, and lower costs. A testament to the transformative power of great design, Exo Iris is the first of many innovations to come that will redefine the medical imaging space. We’re just getting started.”

Designed around the caregiver, Exo Iris blends a simple user experience with powerful, real-time AI to enable even novice users to get instant answers at their fingertips. The company’s patented SweepAI™ technology automatically acquires images with a sweep of the caregiver’s wrist, reducing operator dependence and bias to ensure consistent and accurate imaging. 

Exo Iris comes equipped with Exo’s Bladder AI solution to help caregivers determine bladder volume in seconds. Exo has a suite of additional AI solutions coming soon, including FDA 510k-pending advanced Cardiac and Lung AI suites that provide real-time guidance and answers for caregivers to quickly and accurately diagnose, triage, and monitor heart and pulmonary conditions.

Exo Iris is powered by Exo’s patented pMUT-based technology that blends the imaging excellence of piezoelectric crystals with silicon’s affordability. Exo’s silicon architecture allows for rapid imaging quality evolution and delivers real-time AI capabilities where every frame can be analyzed to guide the user to an immediate answer. The beauty of Exo Iris is that, when paired with this real-time AI, it doesn’t matter who the caregiver is: the same quantifiable answer is possible. 

With this industry-first technology, Exo Iris delivers unparalleled sensitivity for seeing deeper into the body or tracking fine structures, enabling caregivers to scan all major organs and guide IVs and line procedures. In addition, caregivers have access to novel features like an ultra-wide field of view for imaging up to 150 degrees, allowing them to capture an entire liver or full-body fetus in one view. Hospitals can easily connect Exo Iris to existing healthcare IT systems for compliance and storage, whether it be their PACS or VNA. They can also store exams on Exo’s secure cloud environment.

 Additionally, Exo Iris can function without an internet connection, making it essential for caregivers in rural settings and in mobile response. Exo Iris comes equipped with Exo’s point-of-care ultrasound workflow solution, Exo Works™, to seamlessly document and review exams in seconds from anywhere. This combination blends an entire medical imaging ecosystem to perform flawlessly across hospitals, clinics, and at home, making communication across all spectrums of care possible. With Exo enabling system-wide adoption, health organizations finally have an answer for enterprise-level POCUS investment.

What You Should Know: 

– Geisinger has announced their implementation of Exo’s point-of-care ultrasound (POCUS) workflow software, Exo Works, to simplify and streamline ultrasound exam documents, billing and quality assurance to improve patient outcomes.

– The implementation marks Geisinger as the first health system in PA to implement Exo’s easy-to-use ultrasound workflow solution. 

– Exo Works will be deployed in Geisinger’s Emergency, Women’s Health and Sports Medicine departments – with plans to expand its use to 14 other health departments.

What You Should Know: 

• UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. 
• The UltraSight real-time AI guidance software can assist medical professionals without sonography experience in acquiring cardiac ultrasound images at the point of care in multiple settings, allowing for more widespread detection of heart disease and providing patients easier access to cardiac monitoring.

Expanding Patient Access to Cardiac Imaging

UltraSight’s AI Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the 10 standard views of the heart. The company’s submission for FDA clearance was based on its landmark pivotal study which demonstrated that with real-time guidance of the ultrasound probe and feedback on the quality of the ultrasound image, medical professionals without prior ultrasound experience can acquire diagnostic quality images.

UltraSight’s solution will enable hospital staff to advance patient triage and treatment with increased efficiency and clinical confidence. It can also increase access to care for chronic heart disease patients by bringing cardiac ultrasound into local communities, potentially increasing patient adherence to critical treatments. 

UltraSight’s software is designed as an accessory for point of care ultrasound systems and is compatible with the Philips Lumify Ultrasound System. When paired with a compatible device, UltraSight’s underlying AI neural network predicts the position of the ultrasound probe relative to the heart, based on the ultrasound video stream, and guides the user on maneuvering the probe to capture diagnostic quality cardiac images.

Key Trends in the handheld ultrasound market 1 – AI

The steep learning curve and subsequent ultrasound skills shortage are two of the biggest barriers to the wider use of ultrasound. These challenges are exacerbated in handheld ultrasound, where there is a higher proportion of new and less experienced users compared to cart and compact ultrasound. As the expansion of the handheld ultrasound market in the coming years is expected to be strongly driven by new user groups, this barrier will be greater than ever before. These barriers can be partially addressed by AI solutions that guide users with positioning and moving the ultrasound probe.

To date, most image guidance AI solutions, such as those from Caption Health, UltraSight, and DESKi, are for cardiac scans. AI image guidance solutions will have a bigger impact when they can also be used for other clinical applications, making it easier for users such as nurses to use ultrasound during their rounds. Whilst this is starting to happen, with image guidance AI solutions for the thyroid (developed by Medo.AI), women’s health (developed by Pulsenmore) and vascular (developed by ThinkSono), it will take time, capital and data to develop image capture support for other body areas. In the interim, we expect to see more anatomy labeling solutions to assist with image capture.

In addition to AI solutions for image capture support, solutions for image analysis will make ultrasound more efficient for users. These solutions need to be embraced by physicians, some of whom may be wary about the performance and limitations of AI.

For AI solutions to be more widely used in handheld ultrasound, one of the main challenges that will need to be overcome is how the AI solutions are paid for. The solutions need to be affordable to the customer, in line with the price paid for the scanner, yet still, enable AI vendors, and potential OEM partners, to make a profit. Another challenge is validating AI solutions, which can be costly. This is one of the main reasons for the lack of ultrasound AI adoption in China.

Key Trends in the handheld ultrasound market 2 – Teleultrasound

With education being the most significant barrier preventing the adoption of handheld ultrasound, teleultrasound can have a positive influence by connecting novice users with experienced experts. With ultrasound increasingly being taught as part of the curriculum at medical schools, a teleultrasound platform enables newly trained physicians to connect with ultrasound experts to help them become more comfortable in using ultrasound in real-life cases and get a second opinion on a diagnosis.

With the current backlog of patients requiring imaging and changes in reimbursement, there is a drive to move imaging to out-of-hospital settings, and teleultrasound platforms, along with other digital solutions, can play a role in facilitating this shift.

Table 1 –Teleultrasound solutions available in the handheld ultrasound market

Key Trends in the handheld ultrasound market 3 – Diverging Business Models

During the early years of handheld ultrasound, most devices were purchased with a one-time payment (capital expenditure). This payment model is familiar and accepted by healthcare providers and enables vendors with a broad range of ultrasound systems to sell handheld scanners to their existing customer base as an “add-on” with bundled deals. More recently, a new breed of dedicated handheld ultrasound vendors, like Butterfly Network, Vave and Clarius, have introduced subscription payment models. Due to the low cost of handheld ultrasound devices, with the global average selling price now down to around $4,000, vendors need large sales volumes to make a profit. This is a challenge as handheld ultrasound has not yet achieved mainstream adoption. As such, most dedicated handheld ultrasound vendors are not yet profitable.

Vendors are now seeking subscription revenue streams, either to replace the upfront payment for the device or to supplement the initial device purchase, to generate additional and recurring revenue. Vendors are now launching digital solutions that are chargeable add-on services, such as teleultrasound and AI applications. Moreover, the subscription model enables vendors to lower the initial cost of the device, opening the market to cost-sensitive customers, such as new users of ultrasound.

Competitive Analysis

The leading vendors of handheld ultrasound are Philips, Butterfly Network, GE HealthCare, and Clarius. The largest Chinese handheld ultrasound vendors are SonoStar, Youkey, and Stork Healthcare. These vendors are mostly focused on their domestic market, except for SonoStar which has had some limited success in Western Europe and the USA.

Whilst the market was initially dominated by vendors such as GE HealthCare and Philips, with a full ultrasound product portfolio, dedicated handheld vendors are becoming increasingly prominent. Whilst initially competing with other ultrasound system types, notably low-end compact systems, handheld ultrasound vendors are increasingly developing customer bases distinct from users of compact systems. This trend will increase as handheld ultrasound becomes more mainstream and is adopted by increasingly newer users of ultrasound in new use cases such as in plastic surgery and medical aesthetics.

Whilst the majority of handheld ultrasound sales are wired devices, accounting for around 75% of handheld ultrasound sales revenue in 2021, wireless handheld ultrasound devices are expected will dominate the market in the future. The current product mix of wired versus wireless devices in the market is due more to the supplier mix than customer need, as most vendors currently offer wired devices. Amongst the larger handheld ultrasound vendors, Butterfly Network and Philips only offer wired devices and GE Healthcare launched its first wireless device in 2021.

The Signify View

The outlook for the handheld ultrasound market is promising, with a projected 2021-2026 CAGR of 24.7%. Growth will be driven by existing ultrasound users, either to replace compact systems or as an adjunct to existing systems, as well as new users of ultrasound such as nurses, primary care physicians and midwives. Some vendors are also promoting the use of handheld ultrasound to enable patients to self-scan in the home setting.

Primary care is forecast to be the fastest growing clinical application for handheld ultrasound, with growth propelled by increased adoption of handheld ultrasound by primary care physicians. It is estimated that the percentage of primary care physicians that use ultrasound is in the single digits in most countries. The lower cost and ultra-portability of handheld scanners is expected to notably increase the use of ultrasound in primary care.

The use of ultrasound in plastic surgery and medical aesthetics, to improve procedure safety, is expected to be one of the fastest-emerging applications of handheld ultrasound, especially in Western Europe and the USA. Ultrasound will increasingly be used by plastic surgeons to differentiate their practice and reassure customers of the safety of cosmetic procedures.

About Mustafa Hassan

Mustafa joined Signify Research in 2020 as part of the Medical Imaging team which covers areas such as ultrasound, general radiography and machine learning in medical imaging. Prior to that he obtained a PhD in Pharmacy and Physiology from the University of Kent and has three years of post-doctoral experience working on optimising healthcare for genetic Cardiac diseases. 

What You Should Know:

– GE HealthCare acquires Caption Health, Inc., a privately owned artificial intelligence (AI) healthcare leader that creates clinical applications to aid in early disease detection, using AI to assist in conducting ultrasound scans.

– The acquisition supports GE HealthCare’s $3B Ultrasound business by adding AI-enabled image guidance to ultrasound device portfolios. In addition, it aligns with strategy to deliver precision care and expands access to new ultrasound users and clinical uses.

FDA-Cleared AI-Guided Ultrasound Technology

Founded in 2013, Caption Health delivers AI systems that empower healthcare providers with new capabilities to acquire and interpret ultrasound exams. With Caption AI applications, ultrasound examinations can be easier and faster, enabling a broader set of healthcare professionals to conduct basic echocardiogram exams. This technology can help detect signs of diseases like heart failure in at-risk patients across doctors’ offices, the home, and alternate sites of care, potentially preventing hospitalizations and supporting improved clinical outcomes.

As part of this acquisition, Caption Health will continue to provide management and administrative services to affiliated medical services providers (collectively referred to as “Caption Care”). By providing trained technicians across the country equipped with the Caption Health AI technology to perform cardiac ultrasounds in alternate sites of care and, in the future, in the comfort of patient’s homes, Caption Care service is intended to support early diagnosis and detection before diseases like heart failure become more difficult to treat.

Karley Yoder, Chief Digital Officer, Ultrasound at GE HealthCare, who will integrate Caption Health into the broader digital ecosystem of GE HealthCare, said, “We couldn’t be more excited to partner with the Caption Health team to increase access and accelerate growth of ultrasound. Caption Health will first be integrated in the Point of Care and Handheld business portfolio to advance ultrasound adoption, with expanded future use cases as well.”

Financial terms of the acquisition are not being disclosed and GE HealthCare intends to fund this acquisition with cash on hand.

What You Should Know:

– SimX and the U. S. Air Force are announcing a $1.7M expansion of its ongoing effort to advance the future of medical simulation training using virtual reality (VR) technology.

– This effort, housed within the Virtual Advancement of Learning for Operational Readiness (VALOR) program at SimX, aims to enhance the usability and medical capability of virtual simulation training, with a focus on prehospital combat casualty care delivered by the Air Force’s elite special operations medical personnel.

– Funding for this effort was provided by the Department of the Air Force (DAF) under the AFWERX/AFVentures Tactical Funding Increase (TACFI) – Small Business Innovation Research (SBIR) program. The project is managed by the Air Force Life Cycle Management Center (AFLCMC) Special Operations Forces program office on behalf of the DAF.

VR Medical Simulation Training

The project includes a substantial expansion of VR medical simulation training into areas never previously trained using immersive technology, including advanced airway and ventilator management, extrication tools, enhanced portable monitors and ultrasound capabilities, and an improved physiological model for field sedation and paralysis. Additionally, the project aims to substantially increase the reliability and ease of use of VR simulation across the global scope of deployment of technology, including automated self-serve familiarization and simplified training orchestration.

“We couldn’t be more excited about this project,” said Karthik V Sarma PhD, Principal Investigator of the effort and Chief Technology Officer of SimX, “which will accelerate the rapid advancement of VR medical simulation technology as a crucial modality for training healthcare workers in every setting.”

SimX Virtual Reality Medical Simulation System (VRMSS)

The SimX Virtual Reality Medical Simulation System (VRMSS) is widely deployed across the Air Force for use in tactical combat casualty care (TCCC) training, as well as across hundreds of civilian medical organizations for training physicians, nurses, emergency medical technicians, pharmacists, and other professionals. Col Clayton Rabens, Wing Surgeon of the U.S. Air Force 24th Special Operations Wing, said “The enhanced casualty care training capabilities being developed under this project are essential to maintaining the highest level of readiness for a future of large-scale operations conducted against near-peer adversaries. The new capability to train these critical skills in a virtual domain will ensure that our elite operators continue to provide the highest level of care to US and partner force casualties.”

What You Should Know:

– Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, receives 510(k) clearance for its new MSK AI model, which automatically identifies and measures tendons in the foot, ankle, and knee using artificial intelligence (AI).

– The new MSK AI model will be available soon with the Clarius L7 HD3 and Clarius L15 HD3 high-frequency, wireless handheld ultrasound scanners.

AI Driven Imaging To Improve Diagnoses

“Ultrasound imaging has long been recognized by the medical community as the best way to see inside the body in real-time but learning to detect and recognize anatomy comes with a learning curve,” explains Clarius President and CEO Ohad Arazi. “AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound. This application will blow the doors open for physiotherapists and orthopedic clinicians to use ultrasound to deliver faster patient care.”

With the Clarius HD3 line of handheld ultrasound scanners introduced last year, high-definition ultrasound imaging has reached unprecedented levels of affordability and usability. Available starting at 3,395 USD with 595 annual membership, Clarius high-definition scanners are now used worldwide as a more affordable and easier-to-use alternative to traditional compact ultrasound systems.

The Clarius MSK AI model is designed to streamline workflows, inform clinical management, and provide training assistance during musculoskeletal scanning for specific anatomical sites, which include: the plantar fascia (foot), Achilles tendon (ankle), and patellar tendon (knee). The AI analyzes ultrasound imaging in real-time and displays a transparent color overlay to identify the tendon in view. Upon pausing the image, the AI labels the tendon and determines the greatest thickness, automatically placing measurement calipers that correspond to the top and bottom of the tendon at its thickest region. The user may alter the measurement calipers to make any necessary adjustments to support clinical decision-making.

Nate Maslak, the co-founder/CEO of Ribbon Health

Data Personalization: 38% of consumers want more personalized and inclusive healthcare options. In 2023, we’ll see a greater shift towards healthcare enterprises prioritizing this personalization, by innovating their current data infrastructure to show a range of information that lets a patient make an educated care decision based on what matters most to them.

Julian Harris, MD – CEO of ConcertoCare

There are 76 million baby boomers who will be 65 by 2030, and they want a better, easier way to receive health care where they prefer it most — in their homes. In 2023, I expect we will continue to see accelerated demand for and investment in tech-enabled delivery of at-home care for seniors, especially given the growing prevalence of chronic conditions in this age group and the impact that has on healthcare spending and outcomes in the country. As we head into 2023, there’s a real opportunity for CMS to strengthen the value-based care models that make this type of innovative care happen.

Amy Brown, CEO of Authenticx

Companies throwing technology at their staffing shortfalls — without first understanding the problem they’re solving for and how it actually impacts the customer experience — will be an utter failure. Spending millions of dollars on the latest digital innovation or optimization transformation won’t solve the patient experience and will ultimately hurt the company’s business. Some healthcare organizations say they’re in the business of improving patient experiences when they’re actually digitally optimizing and simply adding more technology to cover staffing shortages or eliminate overhead. Leaders must use technology to listen at scale to patients and know how and when to enable digital solutions and the staff they do have to do their best work.

Oliver Kharraz, CEO & Founder, Zocdoc

Savvy care organizations will increasingly use physician extenders to offer more appointment inventory, grow revenue, and increase access to care.

As the costs of operating a healthcare practice or hospital rise, and staffing and burnout issues add additional stressors, the medical community is facing unprecedented times. Savvy practice and system leaders will make good use of physician extenders, who can help close financial and labor gaps. Physician extenders can help open up more appointment capacity, and reduce the workload of physicians by managing patient communication, filling prescriptions, and taking on relevant clinical tasks. Additionally, higher physician extender to physician ratios can significantly reduce costs by improving physician efficiency; physicians can focus on the more complex cases. Physician extenders will help close the care gap for patients, while increasing revenue for medical practices.

Florian Otto, CEO at Cedar

Healthcare Consumers Will Vote With Their Feet: We’re seeing consumers find and stay with providers that give them the best end-to-end experience beyond just their clinical visit. These days, the quality of a consumer’s clinical visit is now table stakes, and the experience before and after an appointment make the difference between a repeat customer or a one-time visit. Unfortunately, a lot of providers are still offering poor administrative quality. In the coming year, providers must double down on a holistic experience, both in-person and digital, to put the consumer at the center of the healthcare ecosystem. To do so, providers will need to think beyond their individual relationship with the consumer and instead work with all stakeholders to provide a united source of truth and communication. Those that do will see the greatest amount of return by way of patient foot traffic.

Ariel Katz, CEO & Co-Founder at H1

The US will become the leader in healthcare data democratization. Next year, we’ll see more initiatives aimed at democratizing and digitizing healthcare data so we can use it to foster innovation, bring drugs to market faster, and ultimately improve patient care. While a few countries have set the stage – Brazil’s DATASUS provides an integrated and open healthcare database, and Israel captures all patient data digitally from birth to death – we predict that the US will emerge as the leader in 2023. We’ve seen the value that using de-identified data can have on improving patient outcomes, and with recent federal regulations requiring that patients have digital access to their full health records, US healthcare companies will place a greater emphasis on and investment in data democratization and digitization.

Brett Vokey, Founder and CEO of BreatheSuite

The healthcare industry as we knew it has been forever altered by the global pandemic. Physicians and their patients have increasingly been relying on virtual care and remote patient monitoring (RPM) solutions as the industry evolves to accommodate COVID-19. I expect the forward momentum of virtual care and RPM will continue in the coming year due to their convenience, positive impact on patient outcomes and potential to reduce costs.

For example, 90 percent of people in the U.S. using a Metered-Dose Inhaler (MDI) are using it incorrectly and 66 percent are not adherent to the medication as prescribed (skipping doses, etc.). Inhaler misuse makes up about $5- $7 billion of the approximately $25 billion spent on inhalers annually. While physicians can identify incorrect inhaler technique through visual observation, but it is not possible to critique their patient every time they use a Metered-Dose Inhaler (MDI). Connected respiratory devices leverage technology that tracks, scores and provides cloud-based feedback on inhaler usage to users and, with consent, their care teams can ensure people are getting the most out of their inhaler.

Bronwyn Spira is the CEO and Co-Founder of Force Therapeutics

Since CMS released the new CPT codes for remote therapeutic monitoring (RTM) earlier this year, providers are finally being acknowledged for the time they spend connecting with patients outside the office. In 2023, it will be easier to make high-quality musculoskeletal care more accessible to minority and lower-income populations who are much less likely to have orthopedic surgery – and more likely to experience poor outcomes when they do. RTM, through digital care management tools, can enable individualized care pathways based on the patient’s demographics, social determinants of health, and clinical status. Immediate adjustments to the care plan can be made according to the patient’s reported pain, range of motion, and adherence to remote physical therapy. By enabling high-quality personalized education for patients who may be unable to present for in-person care due to financial, logistical, or motion challenges, a broader set of patient populations can have access to needed care as telehealth is increasingly accepted.

Piotr Orzechowski, Co-Founder and CEO of Infermedica

On the state of healthtech funding: Starting around Q2 we observed a downturn when it comes to venture funding, especially later stage. In fact Q3 ’22 was the lowest quarterly total in digital health funding in the past 11 quarters. Given clear macro-economic challenges and looking at performance of some of the leading public telehealth companies, investors have become more conservative this year but I believe this is a rather temporary trend. Great companies will still get funded, and the amount of capital available in the market is substantial. I believe that starting from Q2 2023 the digital health funding situation will gradually improve and will recover by mid-2024 bringing investor’s sentiment back on track.

Saket Saurabh, Founder and CEO of Nexla

Data Mesh Takes a Backseat But Data Products Will Push on Ahead in 2023: With the economy in a slowdown, we can expect data mesh— frameworks that bring scale to enterprise wide data adoption — to take a backseat. 2023 will be the year of data products before the industry moves towards data mesh in 2024 and beyond.

Yossi Bahagon, Chairman of Sweetch

Closing the Equity Gap: We will see more programs implemented that bridge the equity gaps in chronic care management, obesity, diabetes, and preventive care, among other areas.

Mike Peluso, Chief Technology Officer at Rectangle Health

In 2021, we saw that patients were actively seeking digital tools to the point where they were changing providers to add technology to their healthcare. As the calendar turns to 2022, we expect to see continued growth in popularity of digital healthcare management tools like text communications, digital wallets, text-to-pay, payment plans, and QR codes that point to digital portals.

Practices are seeing the benefits of replacing outdated payment collection processes that involve manual data entry, paper-based billing, and follow-up phone calls. These digital payment options get practices paid faster and increase patient convenience and, in turn, loyalty. The digital transformation is proving not to be a fad necessitated by COVID-19, but a way to find better connections between practices and patients.

Terrence Sims, Chief Strategy Officer, Raintree

The US population is aging rapidly. By 2040 we expect the population of those 65 and older to double. Today non-fatal falls account for $50B in healthcare spending, a number that is unlikely to diminish with an ageing population. However, most falls are preventable, and moving forward fall prevention will be a growing priority. This will drive an increased need for therapists to spend more time working directly with patients, and less time doing paperwork. Our population of care providers is limited, which increases the need for professionals to work as efficiently as possible. In 2023 and beyond, the healthcare industry will be making major technology, operational and manpower investments into solving the non-fatal fall challenge.

Vince King, Chief Commercial Officer at TailorMed

Taking a note from Disney – patient experience at the forefront of healthcare

The pandemic heightened patient demand for digital engagement  – and in 2023, healthcare leaders will lean into the digital acceleration, identifying new avenues to connect with patients and amplify the patient experience. We’ll see more healthcare entities hiring individuals from companies including Disney and Carnival with top-tier customer experiences to optimize the patient journey and experience in a way the healthcare industry has not previously prioritized.  

However, there will be a learning curve as the industry finds a healthy balance of how to engage patients and when. Understanding who the patient is and where they are at each step of their journey will be key to engaging logically and strategically. Patients need the right data at the right time to take the right action – whether that is filling out automated intake forms or engaging in the billing process following care. Aligned incentives across healthcare stakeholders will be critical in this process, working to improve care coordination and delivery. The more successful healthcare is at engaging with patients digitally, the more the industry can ask consumers to engage in more aspects of their care, and the greater momentum we’ll see next year and beyond. 

Chris Luoma, SVP of Global Product Management at GHX

Over the last two years, healthcare has seen increased adoption of solutions like cloud ERPs and electronic invoicing,” said Chris Luoma, Senior Vice President, Global Product Management, GHX. “As the need for digital transformation increases, this trend will continue. We are starting to see provider organizations that were early cloud ERP adopters mature their cloud strategies, allowing them to think about how they can change the way they operate their businesses and drive greater efficiency. Examples of this include deploying ERP into non-acute settings to drive efficiencies that previous, on-premise systems were not able to reach, extending their systems further with robotic process automation, artificial intelligence and machine learning to reduce manual tasks and creating overarching data strategies that bring together financial, clinical and supply chain data to drive insights that help improve patient care. Despite the upfront costs of digital transformation initiatives, we expect to see more forward-thinking healthcare executives make the near-term investment, even amid financial pressures, to support the long-term growth and health of their organizations.

Karen Kobelski, Business Unit Vice President & General Manager, Health, Clinical Surveillance, Compliance & Data Solutions at Wolters Kluwer

Patient safety will improve with regulatory oversight of healthcare technology – particularly around the emerging software in the medical device space. With increasing regulations, hospitals and health systems now face greater hurdles using and maintaining technology built in-house. In 2023, we expect clinical leaders trying to build solutions will experience pushback from internal legal and regulatory teams challenged to manage the burden of compliance. Many hospital leaders will turn to proven, clinically validated, and compliant tools in lieu of building their own solutions. By partnering with companies that have already taken on this burden of compliance, health system leaders will be able to keep internal teams focused on providing the best care to patients.

Dr. George Gellert, Medical Advisor for Value Demonstration at Infermedica

Demonstrating ROI: Despite healthcare IT being central to and a vehicle for not only clinical care delivery, but all operational and financial aspects of health system performance, truly robust evidence-based evaluation of impact, value and ROI remains a “nice to have” rather than an imperative. Most health IT companies are held to a low standard of evidence of value and proof of ROI through marketing white papers and quantification that is not robust or systematically evaluated, rather than being required to demonstrate value through scientific peer review and journal publication. This has not served the interests of health systems and care delivery organizations, clinicians or patients well. Health IT solutions, which profoundly influence and impact care delivery and organizational performance, should have to scientifically demonstrate value – much as drug therapies, medical devices, and other diagnostic and therapeutic technologies do. Only when scientific research on health IT impact and value demonstration is regarded as being as important to healthcare delivery as clinical trials, will spending on health IT become rational and systematic.

Brian Doyle, Rectangle Health’s VP of Enterprise Sales

Following a year of economic uncertainty, increased expenses, and staff burnout, many practices will need to address these challenges and those that lie ahead in the new year. As 2023 approaches, providers seek new solutions to streamline administrative workloads while providing top-notch care. The solution to many of these problems lies in digital transformation: an advanced digital footprint can effectively streamline and automate administrative workloads, improve the patient experience, and mitigate employee burnout — equipping providers and patients with an enhanced healthcare experience.

The benefits of enhancing one’s digital footprint are many. For starters, digital transformation allows patients to sign up for appointments online while allowing practices to manage all appointments on the back end. Customizable texts remind patients of appointments, send links to payments, or announce new check-up openings. Technology can offer several options for patients to pay their medical bills — whether from their mobile device, laptop, or the office with contactless payments like Apple Pay — and offer payment installment programs to help ease the financial burden. Not only does this enhance the overall patient experience, but it also increases the practice’s bottom line. Patients and practices will benefit by simplifying the business side of healthcare through a digital transformation. Starting the new year with an advanced digital footprint gives providers the tools to rise to new challenges and meet evolving patient demands, optimizing the healthcare experience for all.

Marie Lamont, Global RWE Data Strategy, Access & Enablement at IQVIA and General Manager at Inteliquet

Data harmonization on the results of genetic testing and research is required for us to effectively use the millions of data points for more than one trial. By reusing this information across various studies, researchers can have broader insights into uncovering methods to better the lives of patients in a faster manner. The question before us is how to do so and which is the correct data format to standardize on. In 2023, the industry will begin to look at how to solve this challenge to better formulate and build upon the millions of data points already being collected in a cohesive manner.

Arun Nagdev, M.D., Sr. Director of Clinical Education at Exo, and Director of Emergency Ultrasound at Alameda Health System

The siloed nature of healthcare, and how to fix it in 2023: The biggest challenge that physicians face today is the siloed nature of healthcare. Across various care settings, patient-focused medicine is missing, and the losers of this game will always be the patients and their physicians. Moving forward, we should see more patient data flowing into electronic medical records across all care settings – both inpatient and outpatient. This will enable care teams across the continuum to have the insights they need to better, and more efficiently, care for their patients. By providing informed, superior care from the get-go, this will also help prevent patient readmission and backlogs.

By the end of 2022, nearly 42,00 new cases of primary liver cancer will be diagnosed in the United States. In fact, liver cancer incidence rates have more than tripled since 1980, marking an increased need for better detection and diagnosis. 

We might not talk about liver cancer as much as we do breast or lung cancer, but it’s a real threat to millions of Americans – and we need to continue spreading awareness. 

Early detection is especially critical in treating liver cancer. Patients need to know what factors put them at risk and what symptoms can indicate the presence of a tumor. The earlier cancer can be identified, the greater chance of survival and remission.

The State of Liver Cancer Today

Hepatocellular carcinoma (HCC) is the most common type of liver cancer in America and throughout the world. It accounts for 90% of all new liver cancers diagnosed and is the third-leading cause of cancer-related deaths. 

When looking at liver cancer survival rates, it’s important to keep in mind how those rates are determined.

– Localized: there is no sign that cancer has spread outside of the liver (35%). 

– Regional: cancer has spread outside the liver to nearby structures or lymph nodes (12%). 

– Distant: cancer has spread to distant parts of the body, such as the lung or bones (3%). 

Studies show that, like all cancers, the sooner liver cancer is detected, the better the chance for survival. Survival rates are the highest in cases in which surgery or a liver transplant is involved, likely early on in treatment. 

Liver cancer is the sixth most common cancer diagnosed today. Unfortunately, it is often difficult to detect liver cancer early, as the signs and symptoms do not typically appear until the later stages. Small tumors are also challenging to detect in a physical exam – most of the liver is obscured by the right rib cage. This can contribute to late detection and diagnosis. 

Common Liver Cancer Risk Factors

Different cancers have different risk factors – some of which are environmental, others which are biological or hereditary, such as inherited liver diseases. A brief list of common risk factors includes: 

– Smoking

– Poor diet and exercise

– Chronic infections from Hepatitis B (HBV) or Hepatitis C (HCV) 

– Progressive, irreversible cirrhosis that causes scar tissue to develop

– Inherited liver diseases including hemochromatosis and Wilson’s Disease

– Diabetes

– Nonalcoholic fatty liver disease

– Exposure to aflatoxins

– Excessive alcohol consumption

What are some preemptive steps you can take to prevent liver cancer? Although some factors may be out of your control, there are a few things that you can do to help lower your risk:

– Eat a nutritious diet and maintain a healthy weight

– Exercise regularly

– Quit smoking

– Cut down or eliminate alcohol consumption

– Get a Hepatitis B vaccine

– Seek immediate treatment if you have an HBV or HCV infection

Liver Cancer Detection and Treatment

Liver cancer is most commonly detected once individuals begin experiencing symptoms and turn to a doctor. However, it can be detected earlier if the patient goes in for regular screenings and knows they are at risk. 

The most commonly used tests and procedures include: 

– Physical exam with your doctor

– Ultrasound

– Computed Tomography (CT) scan

– Magnetic Resonance Imaging (MRI)

– Biopsy

– Alpha-fetoprotein blood (AFP) test

– Liver function tests (LFTs)

Leading businesses today are empowering people to check for liver cancer early with a simple blood test, and utilizing the power of big data and artificial intelligence to detect cancer at its earliest stages. For the majority of cancers, 90% survive if detected at an early stage.

Factors That Influence Liver Cancer Prognosis

Liver cancer prognosis depends on many different internal and external factors. The stage of cancer, how well the liver is functioning, age, and the patient’s general health are all key factors that affect prognosis. These factors also impact cancer’s response to treatment.

The survival rate does decrease if the liver cancer spreads to nearby organs or to the lymph nodes. If it has progressed to other parts of the body, the five-year survival rate typically lowers to around 3%. That’s another reason to check for liver cancer early and often, especially if you have pre-existing risk factors. 

Unfortunately, HCC is often caught later than many other cancers, and that has resulted in a lower median survival rate of approximately 6 to 20 months. In the United States, the 2 year survival rate is less than 50% and the 5-year survival rate is only 10%. This indicates how crucial early detection is in the treatment of liver cancer. 

Spreading Awareness Helps

Liver cancer awareness is a critical part of protecting people. Technology is changing how we view all cancers, including cancers of the liver. These innovations in early detection have the potential to save millions of lives and reduce cancer’s heavy cost and emotional burden on society. If you or a loved one are at risk or show symptoms associated with liver cancer, don’t wait, be proactive with your health and get tested. It can be as simple as a blood test.

About Justin Chen Li
Justin Chen Li is a founding member of Helio Genomics, an Irvine-based cancer diagnostics firm that’s one of the better-funded medtech companies in Orange County. He oversaw the company’s soft launch of its first product, HelioLiver, via a commercial partnership with $1.3 billion-valued Fulgent Genetics Inc. (Nasdaq: FLGT), led acquisitions that increased the company’s lab space, and closed an oversubscribed $35 million Series B1 funding round led by Fulgent.

What You Should Know:

GE HealthCare announced today that Taha Kass-Hout MD, MS has been named Chief Technology Officer (CTO) to lead the company’s new science and technology organization.

– Reporting to GE HealthCare President & CEO Peter Arduini, Dr. Kass-Hout will help drive GE HealthCare’s D3 precision care strategy, a framework and digital products that emphasize the company’s smart devices, aligned to disease states and enabled by digital. D3 brings data and insights together to optimize the clinical and patient journey and enhances the company’s ability to enable precision care.

– In his new role, Dr. Kass-Hout will work in partnership with GE HealthCare’s four business segments (Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics), regions, and global engineering and machine learning (ML) teams to drive growth through clinical research, patient-centric innovation and advancements to GE HealthCare’s platforms, and digital and ML capabilities.

Dr. Kass-Hout Bio/Background

Dr. Kass-Hout is a health tech and machine learning (ML) leader with a depth of experience, most recently serving as Vice President, Machine Learning and Chief Medical Officer Amazon and Amazon Web Services. He also served two terms in the Obama Administration as the FDA’s first Chief Health Informatics Officer, and Director, Information Science and Informatics for the U.S. Centers for Disease Control and Prevention.

Much has already been written about attendance at RSNA, but from a first-hand perspective, RSNA 2022 could be regarded as a step back toward “normal”. Amongst mostly bustling halls, vendors reported very positive feedback on the volume and quality of customer meetings, with one prominent global imaging vendor citing “We’re signing deals here at the show again – things are looking up”. 

Against this positive backdrop, however, the stark challenges facing radiology in a post-COVID world were very evident. These boil down to three substantial issues: 

– A global shortage of radiologists, technicians, and imaging service-line personnel  

– Increasing demand for imaging services, especially outside of the hospital 

– Inefficient and siloed informatics systems   

While RSNA provided a hint of the cutting-edge future of radiology, in reality, new advanced imaging modality and informatics products exclusive to the 2022 show were relatively thin on the ground.  

The “heady” days of extravagant modality and IT launches may therefore have run their course – above all, and perhaps rightly, reflecting the current tide of economic stressors facing healthcare providers, RSNA was wholly concerned with frugality in 2022.  

Trimmed down vendor booths, a greater focus on efficiency and cost-of-ownership across new product releases were evidently woven amongst the biggest booths. The AI zone had also featured a “refreshed” AI exhibitor group, featuring a mix of increasingly established and assured market front-runners, a myriad of new platforms, plus a few expectant fresh logos hoping to capitalize where others had already failed. Positively, post-COVID market forces had also been at work, shedding previously conspicuous exhibitors (well at least in the case of DeepRadiology) and asking more searching questions about the clinical and economic validity of market participants. Combined, this all pointed to the commercial radiology sector getting a little more “real” about the challenges ahead.    

To be frank, this was not a great surprise, given the sentiment and feedback we have received from the many research discussions conducted prior to the show in 2022.

As all good analysts should tell you, predictions are valuable, but even more so when retrospectively assessed for validity; below, we, therefore, assess how the realities of RSNA 2022 shaped up against our predictions.     

Modality Predictions  

Prediction 1: RSNA 2022 will be a subdued show for major modality vendors  

Correct: Overall, new product announcements were scarce, and for those that were released, many were targeted at filling gaps in portfolios/addressing particular customer segments, as opposed to portfolio-shaping new platforms. This was unsurprising given the COVID-19 distraction and disruption to the innovation cycle, with many vendor discussions pointing to more “disruptive” product releases on the near horizon – the hype for RSNA 2023 is already building.   

Prediction 2: Vendors’ exhibitions will focus on clinical workflows  

Partly Correct: While this was evident on some booths (most notably Canon’s novel booth layout) broadly most vendors have done little to move away from presenting products “in category” e.g., by modality type; while this makes for easy visibility and being directed around the largest booths, the apparently limited focus on care pathways and specific clinical workflows will have disappointed some customers. Moreover, as integrated, multidisciplinary care pathways are increasingly adopted, the industry will need to more acutely demonstrate the lynchpin role of imaging within wider diagnostics and therapy. This is, in part, also down to the slowly changing evolution of business models – until commercial contracting models are more complementary to how care is delivered, and providers are convinced of the value of moving to more progressive models of financing equipment purchasing (managed services, outcome-based risk sharing) this is unlikely to change quickly.      

Prediction 3: Vendors will be keen to highlight total cost of ownership and sustainability  

Correct: For modalities, this was particularly evident across new launches and existing products; from the ongoing “helium-free” debate in MRI, the use of edge AI to reduce the need for contrast agents, smart subscriptions, the potential role of “extremity” imaging leveraging lower-cost imaging devices, to more tangible focus on leveraging remote diagnostics, smarter fleet management service contracts and remote acquisition services. Doing more with the same or less shone through as the leading trend of the show. While this reflects the current focus of the customer base facing a tough period ahead, it was also clear that vendors still have some way to go in ensuring the “solution” offering they promise will deliver substantial long-term cost savings. While many touted substantial savings within bullish marketing, more customer-led and independent long-term evidence is required to fully convince buyers that these savings are realistic.      

Prediction 4: Vendors will be focused on advanced imaging systems  

Partly Correct: broadly the leading imaging modality vendors doubled down on “big iron” as their leading lights at RSNA 2022 yet given the influence of COVID-19 on innovation cycles and the fact many have record order books yet to be delivered for CT and MR, there was understandably fewer headliner grabbers in advanced modalities. What was apparent from vendor discussions, however, was the incoming tide of new CT platforms featuring photon-counting technology in the next two years, spectral CT in the near term, and the increasingly important role AI will play in image reconstruction. Combined, these trends will resonate throughout the rest of the decade for big iron modalities, forming a new era equivalent, but more subtle, to the CT “slice wars” period decades before. It should not be overlooked, however, that innovation was also apparent at lower-price tiers; new mobile X-ray systems, C-arms, ultrasound and even some new modalities (see 4DMedical) were all on show. Ultrasound was the most underserved modality at the show – given its expansion into tens of new clinical applications across the care continuum, the radiology-centric nature of RSNA has led to some dedicated point-of-care vendors and clinical specialists opting to spend their marketing budget at more targeted shows.      

Prediction 5: There will be an emphasis on digitization 

Partly Correct: while undertones of digital trended throughout the imaging modality showcase, as highlighted in prediction 3, many of the software offerings on show were disjointed or still nascent in their availability. Across the categories of pre-acquisition operations, acquisition (and virtual acquisition support), post-acquisition operations and fleet management, new and novel digital technology have received substantial focus and R&D investment, a positive development to support imaging service providers in solving their biggest challenges. However, the integration of these tools and interfacing them into wider imaging informatics and health IT platforms have some way to go, a potential hindrance for adoption. Reassuringly, the growing focus on the use of AI and advanced analytics to support predictive demand forecasting tools and smart scheduling of scans should also be applauded. Given that this technology will not be hamstrung by regulatory barriers, this operational application offers far more tangible benefits to healthcare providers short-term in comparison to some of the venture-funded AI image analysis tools attempting to come to market.        

Imaging IT and AI  

Prediction 1: A busy show for imaging IT and AI vendors  

Partly Correct: at face value, many vendors in AI and imaging IT reported satisfaction with the quantity and quality of engagements with customers and prospects. However, reading between the lines, the growing centralization of decision-making for imaging IT in larger acute hospital networks towards CIOs and CMIOs, both personas which were absent amongst the attendees, is having an impact on the importance of RSNA as a deal-making opportunity. Instead, imaging IT vendors are seeing the most value in keeping existing customers informed on new product developments, while also receiving valuable feedback from front-line users (radiologists) on their recent innovations.  

For AI vendors, “busyness” is a poisoned chalice at RSNA; while many are dependent on RSNA as a showcase for brand-building and greater visibility, a more educated and cynical attendee audience is asking ever-increasingly probing questions on the clinical and economic value of their products. This is no bad thing for a still nascent market sector that has for too long failed to address well the real challenges of integration and commercial viability – with external funding drying up and becoming more selective post-COVID, it will soon be all too evident which vendors have products that will meet the increasingly pressing needs of imaging service providers today, and those that will need drastic strategic change or cease to exist near-term.  

Prediction 2: Efficiency and optimization will be key  

Correct: Similarly, to the theme amongst imaging modality vendors, efficiency and optimization was prominent theme amongst the imaging informatics announcements. Echoing the sentiment of imaging modality prediction 5 above, more frustrating for some users was the apparent disjointed nature of service line provision of these tools from pre- to post-acquisitions. This will come in time, but also perhaps reflects the slow interoperability programs of leading modality vendors that are leading in this segment. Dedicated imaging IT platforms were more progressive around radiologist workflow tools, with new generations of case-load balancing, user-friendly interfaces supporting radiologists managing workloads (and avoiding burn-out) and further progress on viewer and reporting interface consolidation. The same sentiment is echoed across AI, where integrated triage tools continue to gain traction and are becoming better interfaced with reporting workflow and care pathways. Reporting tools also took a further step towards more robust structured reporting, though in practice there appears to be a long road ahead for widespread adoption, despite the obvious future benefits for patient quality and care.    

Prediction 3: Platforms, platforms, platforms  

Correct: specifically targeted to AI, this prediction was a continued theme from previous shows, with vendors from a range of PACS, AV, AI, modality, reporting and workflow all tussling to demonstrate their prowess in AI integration. RSNA 2022 was no different, with a plethora of new and re-booted AI platforms on show and a growing list of partnerships for more mature platforms. In theory, user “choice” is commonly seen as a positive for customers, yet perhaps the inverse is the case in medical imaging AI; too much choice is leading to market inertia and confusion, at a time when imaging service providers have limited resources to assess varied approaches.   

While a clear and standardized route to AI access remains unclear, image analysis tools specifically will be influenced by some wider common market “truths”: the power of imaging IT (e.g. PACS) incumbency in customer road-mapping should not be underestimated; customers really do want tightly integrated AI tools (.pdf results outputs help no-one); the presence of big technology AI service offerings for imaging at the show (Google, Amazon, Microsoft, NVIDIA) is going to promote more self-development of AI by providers, requiring a more flexible platform integration strategy; reimbursable AI image analysis tools remain the primary draw for customers. Viewing the explosion of platforms for AI through this lens suggests many of the newly launched platforms will be short-lived. Moreover, with market forces driving impending consolidation of AI algorithm developers’ mid-term, convincing potential customers to look beyond their existing PACS-based platform or one of a few established leading independent platform vendors will be a hard sell.         

Prediction 4: The consolidation of data  

Wrong: Surprisingly with many AI vendors facing impending funding challenges and many providers tackling resource and operational challenges, discussions surrounding the potential value of imaging data were scarce at RSNA 2022. While VNA 2.0 has been touted for some time (and discussed at length in our research) the practical realities of data consolidation have remained subdued. There was progress on show for imaging IT vendors working on common data consolidation challenges across DICOM-based applications, but wider data ingestion and management of unstructured and interfacing with EMR-based clinical data was nascent. The slow progress of structured reporting is in part to blame, yet fundamentally, many of the new integrated care models and demands for more personal, predictive medicine are doomed to fail without more focus on robust data management technology and breaking down data siloes within healthcare networks. 

In context, this is also a missed opportunity for vendors and providers alike; while still nascent, the growing value of well-structured diagnostic imaging data within the pre-clinical arena is obvious, with cash-rich pharma vendors post-COVID well underway with massive investment in research digitalization and overhaul of drug discovery and clinical trial processes. Providers, not looking beyond near-term operational challenges, have either been blind to this opportunity or looking to capitalize on the “goldmine” of data they hold but are unable to execute on commoditizing the value they hold. For imaging IT vendors, this is a significant, yet undervalued opportunity. At its simplest, robust data management platforms are a good starting point to embed deeper with a customer organization in supporting future data commoditization. The savvier should already be exploring the provision of research-grade “sandbox” toolsets to support data aggregation, cleaning, and de-identification; the bravest will also take this a step further, brokering data deals between providers and pre-clinical consumers.            

Prediction 5: AI beyond radiology  

Mostly Correct: Despite some AI vendors still hanging on to the premise that AI-based image analysis tools offering small iterative improvements in radiology reading efficiency and quality are enough to convince providers to pay substantial sums per scan for use, most of the market has realised AI’s biggest potential value mid-term is probably “downstream”. This view has been buoyed further by substantial reimbursement announced in the US for triage tools in stroke care and the success of vendors such as HeartFlow and Cleerly in cardiac care.   

However, measuring downstream “value” in care pathways is fraught with challenges, as pathways are often complex, and health providers are notoriously poor at measuring economic value, let alone clinical value. Reassuringly, leading vendors in the market are investing heavily in producing real-world clinical evidence to support the case for AI (and to help move payers toward reimbursement); this will also gain greater traction as the inevitable market consolidation drives more comprehensive care or body area solution availability (as smaller AI vendors partner up to remain competitive).  

More disappointingly, the downstream value of AI as a predictive indicator for future disease or care intervention was more subdued at the show, or at least subtler behind the mass of platform announcements and focus on basic results integration from many exhibitors and leading imaging IT vendor platforms. This focus on use of incidental findings in screening or non-emergency imaging again seems obvious if the less well-trodden path for AI, given the potential benefits for payers, providers, and patients. While this may only be a temporary impact given many AI vendors have their backs against the wall financially and the road to commercial viability for population health-based AI-analysis tools is a more challenging route, this may have been an opportunity for some to stand out from the crowd at the show this year.         

About Steve Holloway 

Steve Holloway is the Director at Signify Research, an independent supplier of market intelligence and consultancy to the global healthcare technology industry. Steve has 9 years of experience in healthcare technology market intelligence, having served as Senior Analyst at InMedica (part of IMS Research) and Associate Director for IHS Inc.’s Healthcare Technology practice. Steve’s areas of expertise include healthcare IT and medical Imaging.

While maternal mortality is on the rise in the U.S., pregnancy health has seen little innovation in understanding the underlying biology of disease and is ripe for change. Nowhere is this more evident than in the realm of the prediction of preeclampsia. Fortunately, with new technology on the horizon, doctors will finally be able to predict preeclampsia and other pregnancy complications before they arise by evaluating the underlying biology of each pregnancy expressed through RNA messages. Effectively identifying those at risk will enable critical research and allow clinicians to intervene and women to act, preventing many complications before they occur.

Almost daily, more bad news emerges demonstrating that pregnancy health needs an overhaul in the United States. With a maternal mortality rate of 1 in 5,000 overall, we have the worst rate of any developed nation despite soaring healthcare expenditures.¹ Recently, the CDC announced that 84% of pregnancy-related deaths are preventable.²  One critical driver of maternal morbidity and mortality is high blood pressure in pregnancy, which has also seen a dramatic rise, having doubled over the last 15 years.³ We urgently need to act and reverse this unacceptable trend.

Despite the pressing need, one of the fundamental challenges has been a lack of understanding of the underlying biology of pregnancy complications, and the technology needed to do so. Complications in pregnancy are inherently complex and multifactorial, a fact that has hindered the ability to predict their occurrence. We know that 1 in 10 pregnancies will deliver prematurely, but we have struggled to identify who is most at risk. Similarly, we have also lacked an effective predictor for preeclampsia, a high blood pressure disorder in pregnancy. Thus far, we have fallen short of our goals to intervene and prevent disease. 

Overall, one in five women who become pregnant in their lifetime will experience a pregnancy complication.⁴ For many of them, their complication catches them entirely by surprise, well past the time when any preventive measures would be possible. Despite their complexity, we must find a path forward to understanding the underlying biology of pregnancy complications and address their root causes.

Inability to assess risk hampers the development of innovative therapeutics

The inability to identify those most at risk for disease poses barriers to potential therapeutic interventions – a challenge that has hampered nascent drug development efforts so far. When studying a candidate drug or therapy for a condition that impacts only some pregnancies, the sample sizes required to enroll participants become impossibly large, and studies become infeasible. These same studies would be readily achievable if it were possible to identify which women were most at risk of any given complication.

Hence, pregnancy health urgently needs technologies to better understand its fundamental underlying biology and the biological underpinnings of its complications. It is this type of innovation that will facilitate drug development and start to address the root causes of these complex processes.

RNA: a powerful approach to improve our understanding of pregnancy health

Fortunately, new technology has emerged that may help to achieve these goals, enabling researchers to understand the underlying biology of pregnancy by examining RNA messages found in maternal blood samples taken in the second trimester.⁵ In the most comprehensive look at RNA messages published to date, authors recently discovered that these could be decoded to reveal information about a pregnancy’s health.⁵ They can follow a pregnancy’s development and progression, see which organ systems are forming at a given time, and even provide a due date for the pregnancy that is as accurate as second-trimester ultrasound measurement.

Critically, these RNA messages can be used to identify which patients are more at risk of certain pregnancy complications. Recent peer-reviewed research has shown that RNA messages can identify preeclampsia in 75% of cases months before clinical symptoms appear,⁵ and can also predict spontaneous preterm birth, identifying 76% of patients who would go on to have a preterm birth.⁶

By giving experts the tools they need to predict these pregnancy complications effectively, for the first time, we will enable clinical research that can identify new therapies to reverse the underlying causes of these pathological processes. Beyond these broad research and development implications, the ability to predict preeclampsia and other pregnancy complications will also translate to needed improvement in care at the bedside. Because while innovation in therapeutics is sorely needed, so is innovation in the realm of personalized care. Today, there are known interventions that improve a woman’s chances of developing preeclampsia: the challenge is that until now, we haven’t been able to identify who most critically needs those interventions.

Preeclampsia and the urgent need for improved personalization of care

In the case of preeclampsia, there is much low-hanging fruit to improve the current standard of care. Today, national guidelines must rely on clinical risk factors to identify patients at risk of preeclampsia, a complex process that can be subjective.⁷ We know that this standard is not optimally serving patients: studies have shown that among those at high risk for developing preeclampsia, less than half are receiving standard therapies such as aspirin to reduce their risk of disease.⁸ Of patients at moderate risk, only about 3-6% receive these interventions.⁸

This shortfall is through no fault of clinicians, but instead is the predictable result of having guidelines that have simply been too difficult to implement in practice. This is a problem that many physicians have acknowledged, with one discussion on the subject lamenting, ‘[t]he reality is that, outside of the setting of clinical research, effective implementation of risk-based approaches consistently falls short. In the current health care climate, where providers already feel pressured to get through all essential parts of the clinical encounter, trying to pack cumbersome screening protocols into overloaded visits decreases the likelihood that patients will be adequately screened and offered prophylaxis.”⁹

Lacking a more objective test to evaluate the fundamental underlying biology, clinicians have been left with only these cumbersome risk assessments to understand preeclampsia risk. These assessments are subjective and biased, such as including “low socioeconomic status” in moderate risk factors for preeclampsia risk assessment.⁷ It is not surprising that in many cases, clinicians aren’t recommending targeted preeclampsia prevention when they should be,⁷ nor is it surprising that in many cases, even when aspirin is recommended based on an individual’s risk factors, women don’t feel that the risks truly apply to their unique situation.¹⁰

Fortunately, the promise of technology in the pipeline will remove this complexity and subjectivity from the equation. By giving doctors and expecting parents better tools to objectively predict risk, we can begin to target interventions to decrease the chances of this complication. Pregnant people will be more attuned to the signs and symptoms of preeclampsia and will be able to receive much more personalized care from their care team than is possible today. They will be more likely to be provided aspirin for preeclampsia prevention as well as other interventions, including additional monitoring, exercise recommendations, and education. Understanding the risk of preeclampsia and other pregnancy complications will strengthen the partnership between patients and clinicians, enabling both parties to feel that they are doing everything possible to optimize pregnancy health for their unique situation.

Reversing the current heartbreaking trends

The unacceptable rates of maternal mortality seen in the U.S. today demand immediate action, innovation, and investment of substantial time and energy. Last among developed countries for maternal health¹¹ and with dramatic disparities in care identified, innovation in pregnancy health is critically needed. The faster we can determine who is at risk and understand the underlying biology telling us why they are at risk, the sooner we can reverse these trends, pivoting from today’s position of relative weakness to one of strength and leadership for pregnancy health in the future.

About Alison Cowan

Alison Cowan, M.D., M.S.C.R. has dedicated her career to advancing women’s and pregnancy health. In addition to her role as Head of Medical Affairs at Mirvie, Dr. Cowan is also a board-certified and practicing OB/GYN with over 12 years of clinical experience in both academic and community settings.

About Mirvie 

Mirvie is shaping the future of pregnancy health by providing women, expecting parents and their doctors with an early detection window to intervene before unexpected pregnancy complications become a crisis. The proprietary Mirvie RNA platform uses a simple blood test to reveal vital information about a pregnancy’s unique biology and detect complications months before they occur.

Citations:

1. Hoyert DL. Maternal Mortality Rates in the United States, 2020. National Center for Health Statistics (U.S.) NCHS Health E-stats. Published February 23, 2022. https://stacks.cdc.gov/view/cdc/113967

2. https://www.cdc.gov/media/releases/2022/p0919-pregnancy-related-deaths.html. 

3. Cameron NA, Everitt I, Seegmiller LE, Yee LM, Grobman WA, Khan SS. Trends in the Incidence of New-Onset Hypertensive Disorders of Pregnancy Among Rural and Urban Areas in the United States, 2007 to 2019. J Am Heart Assoc. 2022 Jan 18;11(2):e023791. doi: 10.1161/JAHA.121.023791. Epub 2022 Jan 11. PMID: 35014858; PMCID: PMC9238536.

4. Trends in pregnancy and childbirth complications in the U.S. BlueCross BlueShield. Published June 17, 2020. www.bcbs.com/the-health-of-america/reports/trends-in-pregnancy-and-childbirth-complications-in-the-us#complications

5. Rasmussen M, Reddy M, Nolan R, Camunas-Soler J, Khodursky A, Scheller NM, Cantonwine DE, Engelbrechtsen L, Mi JD, Dutta A, Brundage T, Siddiqui F, Thao M, Gee EPS, La J, Baruch-Gravett C, Santillan MK, Deb S, Ame SM, Ali SM, Adkins M, DePristo MA, Lee M, Namsaraev E, Gybel-Brask DJ, Skibsted L, Litch JA, Santillan DA, Sazawal S, Tribe RM, Roberts JM, Jain M, Høgdall E, Holzman C, Quake SR, Elovitz MA, McElrath TF. RNA profiles reveal signatures of future health and disease in pregnancy. Nature. 2022 Jan;601(7893):422-427. doi: 10.1038/s41586-021-04249-w. Epub 2022 Jan 5. PMID: 34987224; PMCID: PMC8770117.

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7. US Preventive Services Task Force, Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Li L, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Stevermer J, Tseng CW, Wong JB. Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Sep 28;326(12):1186-1191. doi: 10.1001/jama.2021.14781. PMID: 34581729.

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