Digital Health and Informatics | Q4 2023

Digital Health and Informatics | Q4 2023 – Q1 2024 Update

June 4, 2024

Newsletter Update

Katherine Erickson

Senior Associate

Rishikesh Kayathi

Product Manager

Katie Schneider

Associate

Olivia Qiu

Associate

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Highlights & Summary

With this issue, we offer a synthesis of exciting and impactful regulatory updates, product approvals, funding rounds, and M&A activity in the digital health space from the end of 2023 through Q1 2024. Stay tuned for a Q2 2024 update in the next several weeks.

Digital health saw a strong finish to 2023 with product launches and FDA approvals across several applications in Q4. The FDA established a new advisory committee on digital health technologies, aiming to improve the agency’s understanding of the benefits and potential risks associated with these tools to best support their proper use to improve patient outcomes. The women’s health / femtech space saw several exciting companies raising funds to drive product innovation, with new AI integrations and capabilities announced in informatics / healthcare IT solutions.

Q1 2024 was also eventful, with initiatives from the White House establishing AI governance in healthcare and increasing funds for innovation and research in women’s health. The FDA provided an update regarding medical device premarket approval (PMA) safeguard requirements. New 501(k) clearances were announced across AI / imaging, disease management & therapeutics, and informatics / healthcare IT solutions, establishing a robust digital health landscape to kick off the year. We look forward to new and interesting developments in the space as 2024 progresses.

We bring you the most relevant snippets in digital health.

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Overarching Industry Updates

1 | FDA Establishes New Advisory Committee on Digital Health Technologies

The FDA has established a Digital Health Advisory Committee to address complexities surrounding digital health technologies such as AI/ML, virtual reality, and wearables. The committee aims to provide insights on the benefits, risks, and clinical outcomes associated with digital health technologies, ensuring they meet the needs of diverse populations while supporting innovation. This initiative reflects the FDA's commitment to advancing health equity and maintaining a balance between regulatory standards and fostering technological advancement in healthcare.

2 | Vice President Harris Announces OMB Policy to Advance Governance, Innovation, and Risk Management in Federal Agencies’ Use of Artificial Intelligence

The Biden Administration announced new policies from the White House Office of Management and Budget governing the use of AI at federal agencies, including many focused on healthcare. By December 1, 2024, agencies will be required to implement safeguards when using AI in a way that could impact Americans’ rights or safety. These safeguards apply to a wide range of AI applications; for example, when AI is used in the federal healthcare system to support critical diagnostics decisions, a human being is required to oversee the process, verify the tools’ results, and ensure disparities in healthcare access are prevented. This initiative reflects a broader emphasis on caution in the midst of excitement surrounding AI, especially when it is used for medical and healthcare applications.

3 | FDA Announces Draft Medical Device Premarket Approval Update

The FDA updated its premarket cybersecurity guidance for medical devices on March 13th. The update clarifies what devices are covered, how manufacturers should document compliance, and how they should handle security vulnerabilities. Any device with the ability to connect to the internet will now be covered by the guidance. Manufacturers are required to have a plan to disclose potential device vulnerabilities; the update also recommends that manufacturers have a plan that outlines how they will routinely develop and release updates that correct their devices to ensure device cybersecurity.

AI / Imaging

1 | NVIDIA and Johnson & Johnson MedTech Partner to Integrate AI into Surgery

NVIDIA is working with Johnson & Johnson MedTech to enable an open ecosystem for AI innovation for surgery that can accelerate the delivery of real-time insights at scale to support medical professionals. J&J MedTech can accelerate the infrastructure needed to deploy AI-powered software applications for surgery by synergizing with NVIDIA’s IGX edge computing platform and Holoscan edge AI platform for building medical devices. This partnership is ultimately aimed to provide a common AI compute platform to facilitate deployment of third-party models and applications that can be used across the digital surgery ecosystem.

2 | Hologic’s Genius Digital Diagnostics System is the first FDA Cleared AI-powered Digital Cytology Solution

Hologic’s Genius Digital Diagnostics System has been granted marketing authorization from the FDA. The system provides a more accurate detection of cervical cancer screening over the traditional manual image-guided cytology review. The Digital Diagnostics System converts glass Pap test slides into digital images, then uses downstream AI image analysis tools to identify precancerous lesions and cervical cancer cells. This will ultimately boost Hologic’s portfolio together with their 3D mammography system to advance digital health offerings.

3 | DeepLook Medical Secures $1.7 Million to Revolutionize Cancer Detection in Dense Breasts

DeepLook Medical, a health tech company, has developed an AI tool to detect breast cancer in women with dense breast tissue, whose cancers are often masked on mammograms. The software, based on a shape recognition algorithm, aims to enhance early detection, assist clinicians in treatment planning, and improve workflow efficiency. Nearly half of women over 40 have dense breast tissue, making them more prone to breast cancer. The tool claims to "see through" dense tissue, helping radiologists navigate and improve confidence in cancer detection. The technology is currently available in the U.S., with certifications for other regions pending.

4 | RapidAI Announces A Series Of Industry Firsts – Unique Rapid Edge Cloud Platform, Breakthrough AI Non-Contrast CT Suite, International Expansion In Japan

RapidAI has reached significant milestones in advancing its cutting-edge clinical AI technology. Among these achievements is the launch of Rapid Edge Cloud, a hybrid healthcare platform combining cloud and on-premise capabilities to provide faster, more secure, and flexible solutions with seamless integration into hospital and third-party applications. RapidAI has also obtained Class III Shonin clearance in Japan, positioning itself as the sole advanced stroke imaging platform for mechanical thrombectomy determination. The company has also introduced a breakthrough suite of non-contrast CT solutions for stroke, facilitating early identification of suspected stroke cases to expedite treatment decisions and improve patient outcomes. Rapid Edge Cloud stands out as a highly-flexible hybrid platform ensuring uninterrupted care delivery even in scenarios where cloud connectivity is compromised, while enabling seamless integration of additional AI systems and algorithms.

5 | Philips Launches New-AI Enabled Innovations at #RSNA23 That Free Healthcare Providers to Focus on Patient Care

Royal Philips has unveiled new AI-enabled cloud solutions at #RSNA23 with the aim to increase radiology efficiency and clinical confidence. New releases include ultrasound systems EPIQ Elite 10.0 and Affiniti, offering a single user interface combined with shared transducers and automated tools; BlueSeal MR Mobile, the world’s first and only mobile MRI system with helium free operations to broaden patient access to MRI exams; cloud-based PACS with AI-enabled clinical and operational workflows in Philips HealthSuite Imaging; Philips AI Manager, an end-to-end AI enablement solution that can integrate with client IT infrastructure; and new digital x-rays including Philips Radiography 7000 M, 2300 C, and next-gen image guided therapy system Azurion 7 B20/15 biplane configuration.

6 | Lunit Receives 510(k) Clearance from the U.S. FDA for its 3D Breast AI Solution; Secures $150 Million in Capital Increase with Over 100% Shareholder Participation

Lunit, a leading provider of AI-powered solutions for cancer therapeutics, has received 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. DBT imaging, contrasted with traditional breast cancer imaging using 2D mammography screenings, is faster and more accurate. Lunit INSIGHT DBT uses an AI algorithm to analyze 3D DBT images. The company also secured a $150 million capital increase to invest in operational costs and expansion in U.S. and Europe markets, with over 100% shareholder participation in the effort.

Disease Management / Digital Therapeutics

1 | FDA Clears First Over-the-Counter Continuous Glucose Monitor from Dexcom

The FDA has cleared the first over the counter continuous glucose monitoring device, the Dexcom Stelo Glucose Biosensor System which is intended for anyone 18 years or older who does not use insulin and does not have hypoglycemia. This approval allows individuals to purchase a continuous glucose monitor without involvement from a health care provider, expanding options for personal health monitoring. The Stelo Glucose Biosensor System is paired with a user installed application to record and analyze glucose values.

2 | Cedars-Sinai Launches AI Mental Health App on Apple Vision Pro

Cedars-Sinai physicians have created an application called Xaia, eXtended-Reality Artificially Intelligent Ally, on the Apple Vision Pro to offer users an immersive therapy session led by a trained digital avatar mimicking a human therapist. The application was a culmination of years of research led by Cedars Sinai to create an immersive platform that is not only engaging to patients but deeply personal and a step to making quality therapy accessible to all.

3 | Google’s FitBit and Quest Diagnostics Partner to Study How Wearable Technologies Can Improve Metabolic Health

Fitbit and Quest Diagnostics announced a study partnership to investigate the effects of wearable devices on metabolic health. The Wearables for Metabolic Health (WEAR-ME) study will enroll approximately 1,500 Fitbit users to share three months of their Fitbit data together with the opportunity to receive free laboratory testing using a panel of blood tests from Quest. While data in the past has shown how wearables can influence users’ metabolic health through factors like diet, exercise, and sleep, this study aims to assess those outcomes through objective laboratory tests that measure markers like blood sugar, cholesterol, and triglycerides. This study will ultimately help us understand how biometrics measured by wearables impact metabolic health.

4 | VA Deepens AppliedVR Partnership to Expand Access to Immersive Therapeutics

The Veterans Health Administration is partnering with AppliedVR to make virtual reality-based therapy more accessible for treating chronic pain. AppliedVR’s program, called RelieVRx, was granted marketing authorization by the U.S. FDA in 2021 for chronic lower back pain and consists of a headset and software guiding patients in pain management exercises. The VHA’s VA Immersive division has been committed to testing innovative healthcare technologies like VR and AR solutions. This partnership will enable doctors at 16 VA facilities to prescribe RelieVRx.

5 | Best Buy Health Expands Digital Health Offerings with Multiple Partnerships

Best Buy Health (BBH) partnered with Mass General Brigham to advance their delivery of care to patients at home and Israeli healthtech startup Biobeat’s wrist and chest monitors to expand their remote patient monitoring solutions. Mass General Brigham’s Home Hospital is one of the largest acute home-based care models where patients receive access to best-in-class services at Brigham, and together with Best Buy Health, will develop customized solutions to enhance the care experience. BBH will also feature Biobeat’s wearables as part of its remote patient monitoring solution with real-time data on blood pressure, heart rate, and respiratory rate.

6 | Soundwave Hearing Receives 510(k) Clearance for Self-Fitting OTC Hearing Aids

Soundwave Hearing has received 510(k) FDA clearance for its Sontro Self-Fitting over the counter hearing aid, which combines mobile technology with AI calibration to self-fit and amplify sounds for individuals with mild to moderate hearing loss. Just last year, the FDA established a new rule that allowed the sale of over-the-counter hearing aids to individuals with hearing loss, which previously required a doctor’s prescription. The hearing aids are used in conjunction with the company’s otoTune app, which is engaged while the aids are worn to customize the self-fitting process.

Women’s Health / Femtech

1 | President Biden Issues Executive Order and Announces New Actions to Advance Women’s Health Research and Innovation

The Biden-⁠Harris Administration announced a comprehensive new initiative to improve women’s health research and healthcare. The initiative includes a $12 billion investment proposal for a new Fund for Women’s Health Research at the National Institutes of Health and a nationwide network of research centers. Multiple federal agencies will take new action, including mobilizing teams to evaluate artificial intelligence/imaging and diagnostic technologies and devices for new applications in women’s health. The initiative aims to address research gaps, improve women’s healthcare delivery, and ultimately improve the health of women throughout their lifespan.

2 | Novii+ Wireless Maternal and Fetal Monitoring Solution Wins FDA 501(k) Clearance

GE Healthcare has obtained FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, consisting of a wearable and wireless sensor for noninvasive measurement of fetal heart rate, maternal heart rate, and uterine activity for pregnant patients at or beyond 34 weeks. The clearance allows expanded use in high-risk pregnancies, offering a personalized view of maternal and fetal statuses with alerts for changes in heart rate and contraction patterns during labor. The device, waterproof and suitable for use during a shower, also has an improved algorithm designed to cross-reference and validate data. This development follows a $44 million investment from the Bill and Melinda Gates Foundation in September 2023 to advance AI-enabled ultrasound technology by GE Healthcare.

3 | OOVA Launches Perimenopause Hormone Kit, First-of-its-Kind Estrogen Biomarker and App with Real-Time Data Tracking

Oova, a U.S. women's health startup, has introduced an at-home hormone kit designed to support women during perimenopause. The kit tests multi-hormone biomarkers, including estrogen (E3G), and comes with an app that tracks data in real time. Unlike other options, Oova's kit allows users to measure hormone fluctuations across a 15-day period throughout a single cycle. The test strips are scanned into an app that uses AI and machine learning to interpret results, offering valuable information for both women and their physicians. The launch follows Oova's $10.3 million funding round in Q3 2023.

4 | Freya Biosciences Announces $38 Million Series A Funding to Advance Women’s Reproductive Immunotherapies and Advance Multi-Omics Data Science Platform

Freya Biosciences, a biotech company specializing in women's health, secured $38M in series A funding to advance development of their vaginal microbial immunotherapy for the treatment of infertility in women with dysbiotic vaginal microbiota who are undergoing assisted reproductive technology (ART). The company also plans to fund their multi-omics data science platform, which includes microbiome sequencing and immune biomarker profiling using human samples.

5 | Philips Receives $60M in Total Funding from the Bill & Melinda Gates Foundation to Accelerate Global Adoption of AI Algorithms to Identify Abnormalities During Pregnancy

Philips has received a second round of funding from the Bill & Melinda Gates Foundation to advance the global adoption of AI algorithms on its Lumify Handheld Ultrasound. The AI technology aims to simplify key measurements for identifying abnormalities during pregnancy, reducing training time on the ultrasound system from weeks to hours. The new funding will support deploying this AI-assisted tool to communities worldwide to address preventable causes of maternal deaths during childbirth.

Informatics / Healthcare IT Solutions

1 | Ionic Health Receives FDA 510(k) Clearance for nCommand Lite

Brazil-based Ionic Health, a partner of GE Healthcare, gained clearance for nCommand Lite. The solution provides diagnostic imaging centers with real-time scanning, remote recommendations and operational assistance, and the power to view images remotely. nCommand Lite interacts with local technicians, and enables remote use of MRI, CT, and PET scans. With newfound clearance, Ionic’s nCommand Lite is set to go to market in the U.S., where GE Healthcare will act as the distributing body. Ionic Health and GE Healthcare have received several 510(k) clearances, including others in the healthcare IT solutions space.

2 | Blue Heron Capital Invests in Redi Health to Modernize Patient Support Services and Expand Healthcare Access

Tech-enabled health management platform, Redi Health, closed a $14 million Series B funding round led by Blue Heron Capital. Redi Health offers a patient-facing mobile app and web platform that includes both medication and symptom tracking. It also enables the connection of healthcare companies, providers, pharmacies, and payors. Redi Health previously received $3.7 million in a 2022 funding round.

3 | care.ai and Virtua Health Partner to Bolster Hybrid Care Providers’ Virtual Offerings

AI-enabled care facility automation platform care.ai announced a partnership with Virtua Health, a not-for-profit hybrid care provider. The partnership allows Virtua to leverage care.ai’s virtual offerings, including the Smart Care Facility Platform and Always-Aware ambient sensors. The Smart Care Facility Platform allows Virtua to enable a network of sensors that monitor patients with AI, allowing for real-time data collection to inform clinical and operational outcomes. This is the latest partnership for care.ai which also recently partnered with several remote monitoring companies, hospitals, and large-scale electronics company Samsung.

4 | Visage Imaging Launches Diagnostic Imaging Platform for Apple Vision Pro

Visage imaging, a diagnostic imaging and multimedia company, announced the launch of Visage Ease VP, an immersive imaging platform for use on Apple’s virtual reality Apple Vision Pro. Visage offers cloud based, AI-powered software, that enables users to review diagnostic images and remotely collaborate. Visage Ease VP allows users to leverage the Apple Vision Pro to examine images in a virtual, spatial environment, using a cinematic rendering engine to generate the environment. UC San Diego Health will be the first health organization to pilot the new technology.

5 | Layer Health, Spun Out of MIT, Launches with $4M from Google Ventures, General Catalyst, and Inception Health

Layer Health, emerging from MIT, has initiated its journey in the healthcare AI space with a $4 million investment from notable backers including GV (Google Ventures), General Catalyst, and Inception Health. Its AI platform, Distill, harnesses machine learning and large language models to refine the chart review process, transforming unstructured data into actionable insights. Distill is designed for seamless integration into current healthcare systems, supporting tasks such as quality measurement and real-world evidence curation without requiring labeled data. This launch is part of a broader trend where companies like Pieces Technologies and Florence are also making significant strides in integrating AI to optimize healthcare workflows, with efforts ranging from improving EHR clinical workflows to enhancing patient engagement and management.

6 | Pieces Technologies Partners with AWS to Integrate AI Tech in Clinical Workflow Platform

Pieces Technologies has introduced Sculpted AI, leveraging Amazon Web Services' generative AI to enhance healthcare systems and integrate with electronic health record workflows. This innovation autonomously drafts clinical summaries and aids in identifying patient care needs, including discharge barriers and health determinants. Customizable to specific healthcare settings, Sculpted AI combines advanced AI with human oversight for rapid, safe implementation, aiming to reduce administrative burdens and improve patient care by embedding AI directly into clinical workflows.

7 | Wolters Kluwer Strengthens Clinical GenAI Offerings with AI Labs Powered by UpToDate

Wolters Kluwer Health has enhanced its UpToDate clinical decision support (CDS) platform with generative AI capabilities, aiming to facilitate more efficient collaboration among healthcare teams. UpToDate provides evidence-based guidance to support improved patient care, enabling clinicians to swiftly find the most pertinent and recent medical information, thus reducing administrative and cognitive loads. The company is also creating AI Labs to allow safe experimentation with generative AI on trusted content, reflective of efforts in the field to deliver reliable and efficient innovations in healthcare.