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Highlights & Summary
The third quarter has come to a close, with numerous developments including partnerships across digital therapeutics and informatics, and regulatory approvals in AI / imaging. Additionally, we announce the addition of a new women's health / femtech section to the newsletter. Innovations in women's health span the categories of digital health and informatics, and we look forward to tracking excitement and updates in the space.
Overarching Industry Updates
1 | FDA releases updates to final guidance for its Breakthrough Devices Program
2 | FTC, OCR send warning letter to hospitals about online tracking pixels
AI / Imaging
1 | GE Healthcare Rides High with $44M Gates Grant and FDA Green Light for Mobile Monitoring
2 | Nesa Medtech's FDA Clearance for Fibroid Mapping Tool
3 | Google's Double Play: Funding AI Health Projects & Unveiling Fitbit Charge 6
4 | Genesis Therapeutics Closes Oversubscribed $200 Million Series B
Disease Management / Digital Therapeutics
1 | New VR program at Flinders University promotes exercise among people with intellectual disabilities
3 | Babylon Health sells majority of UK assets to eMed
4 | Smartlens receives $6.1M for contact lens for glaucoma detection
Women’s Health / Femtech
1 | Natural Cycles Receives FDA Clearance to Integrate birth control app with Apple Watch data
2 | UMass Amherst and Embr Labs Develop ‘Digital Drug’ to Predict Hot Flashes
3 | Molina Healthcare Partners with Mae to Provide Pregnancy Support Digital Platform
4 | Maven Clinic and Amazon partner to offer fertility & family building support in 50 countries
5 | Visana Raises $10.1M Seed Round to Bring Comprehensive Virtual Healthcare to Women
Informatics / Healthcare IT Solutions
2 | Teladoc Health Expands Collaboration in AI with Microsoft to Address Healthcare Workforce Crisis
3 | Blue Shield of California partners with Microsoft for integrated data hub
Overarching Industry Updates
1 | FDA releases updates to final guidance for its Breakthrough Devices Program
The FDA Center for Devices and Radiological Health has released updated final guidance for its Breakthrough Devices Program, emphasizing the safety, effectiveness, and healthcare equity aspects of medical devices. The guidance clearly defines what makes a device "more effective," accounting for the device's overall impact, benefits and risks, and its potential clinical significance compared to the standard of care. It also introduces the possibility of including certain medical products for addiction and pain treatment in the program. Notably, the FDA will now consider improved device accessibility during the Breakthrough designation process, aligning with the program's goal of expediting access to devices for life-threatening conditions. The guidance builds on the draft version released in 2022, aiming to reduce healthcare disparities. Finally, the FDA highlighted its Total Product Life Cycle (TPLC) Advisory Program Pilot (TAP) program, facilitating earlier collaboration between industry stakeholders, healthcare providers, and patients to enhance device development and streamline commercialization processes.
2 | FTC, OCR send warning letter to hospitals about online tracking pixels
The Federal Trade Commission (FTC) and the U.S. Health and Human Services Office for Civil Rights (OCR) have sent a warning letter to 130 health systems and telehealth providers, highlighting the potential HIPAA risks associated with using third-party tracking tools like Meta/Facebook pixel and Google Analytics. These tools can impermissibly disclose protected health information, posing privacy and security concerns. The agencies stressed that even if healthcare organizations rely on third parties for website development and don't use tracking data for marketing purposes, they are still obligated to protect against impermissible health information disclosures under the FTC Act and the FTC Health Breach Notification Rule. This initiative aims to safeguard patients' sensitive health data and raise awareness about the risks associated with online tracking technologies in the healthcare sector.
AI / Imaging
1 | GE Healthcare Rides High with $44M Gates Grant and FDA Green Light for Mobile Monitoring
GE Healthcare is making notable advancements in healthcare technology. The company received a $44 million grant from the Bill and Melinda Gates Foundation to develop AI-enabled ultrasound tools aimed at improving maternal and pediatric care in low- and middle-income countries. These tools will be developed by Caption Health, a company acquired by GE Healthcare, and will assist less experienced healthcare providers in performing ultrasound scans more efficiently. On another front, GE Healthcare's Portrait Mobile, a smartphone-sized wireless monitoring device, has received FDA 510(k) clearance. Designed for in-hospital use, the device enables continuous vital sign monitoring, aiding in the early detection of patient deterioration and improving clinical outcomes.
2 | Nesa Medtech's FDA Clearance for Fibroid Mapping Tool
Indian femtech company Nesa Medtech has received FDA 510(k) clearance for its Fibroid Mapping Reviewer Application. The tool assists in diagnosing and planning interventional procedures for patients with uterine fibroids by generating a 3D model of the uterus from ultrasound images, allowing physicians to locate and measure fibroids.
3 | Google's Double Play: Funding AI Health Projects & Unveiling Fitbit Charge 6
Google announced it is providing $3 million in funding each for 15 AI-powered projects, eight of which are focused on digital health solutions ranging from AI-enabled platforms for low-resource hospitals to machine learning toolkits for midwives in rural areas. On the hardware side, Google launched Fitbit Charge 6, featuring AI and machine learning for more accurate heart rate readings, built-in Google services, and compatibility with gym equipment. The Charge 6 also offers enhanced security measures to protect user data during workouts, further supplementing Google’s digital health offerings.
4 | Genesis Therapeutics Closes Oversubscribed $200 Million Series B
California-based AI drug discovery startup Genesis Therapeutics has raised $200 million in a Series B funding round, bringing their total funding to $280M. The company plans to use the funds to move into clinical development and expand its AI platform, Genesis Exploration of Molecular Space (GEMS). This platform merges deep learning and molecular simulations to create high-potency small-molecule drugs.
Disease Management / Digital Therapeutics
1 | New VR program at Flinders University promotes exercise among people with intellectual disabilities
Researchers at Flinders University in Australia have developed a groundbreaking virtual reality program aimed at promoting regular physical exercise among individuals with intellectual disabilities. The eight-week exercise program allows 16 participants to engage in exercise using popular game apps, with their heart rate, perceived exertion, and intensity volume monitored to track physical improvements. Many Australians with developmental disabilities are not meeting recommended physical activity levels, which increases their risk of cardiovascular diseases; the initiative addresses this issue, often caused by limited access to mainstream fitness services. The decreasing cost of VR systems offers a scalable solution to motivate and engage those with intellectual disabilities in regular exercise.
Headspace, the digital mental health company, has teamed up with Castell, the value-based care subsidiary of Intermountain Health, to offer on-demand behavioral health services to select insurance plan members in Utah. Castell's providers will have the ability to refer members directly to Headspace for behavioral health coaching and therapy, integrated into Castell's care model. This partnership aims to provide a more holistic approach to patient care, addressing mental health alongside physical health. Headspace has been expanding its collaborations in the digital mental health space, extending its reach to improve patient well-being.
3 | Babylon Health sells majority of UK assets to eMed
Babylon Health, a London-based digital health company, has sold the majority of its U.K. assets to eMed Healthcare U.K., a subsidiary of U.S.-based eMed, following the cancellation of its merger plans with Swiss tech firm MindMaze. The sale includes Babylon Healthcare Services Limited, a U.K.-based telehealth practice focused on preventative care. Notably, Babylon's app G.P. at Hand, which serves NHS customers in London, remains outside the deal. The move is seen as part of Babylon's efforts to stabilize its financial position and explore new avenues for proactive healthcare.
4 | Smartlens receives $6.1M for contact lens for glaucoma detection
California-based ophthalmology tech firm Smartlens has raised $6.1 million in a Series A equity financing round led by Ambit Health Ventures, with participation from Stanford University and other investors. Smartlens specializes in miLens, a high-tech, electronics-free soft contact lens that utilizes microfluidics technology to monitor intraocular pressure fluctuations. This technology helps identify early signs of glaucoma, a leading cause of blindness, in the approximately three million affected Americans. The funds will be used to secure regulatory clearance for miLens, which has the potential to significantly improve glaucoma treatment and prevent permanent vision loss.
Women’s Health / Femtech
1 | Natural Cycles Receives FDA Clearance to Integrate birth control app with Apple Watch data
Natural Cycles, a fertility monitoring app, conducted a clinical evaluation to determine the accuracy of using temperature data from the Apple Watch for their algorithm. They collected data from 272 women, comparing wrist temperature measurements from the watch to oral thermometer readings, alongside LH test results for ovulation detection. The study found that the Natural Cycles algorithm identified ovulation accurately with Apple Watch data, resulting in less than a 2% difference in the number of "Green Days" compared to the oral thermometer. The FDA cleared the Apple Watch integration as safe and effective, allowing the app's use for contraception in the United States, Europe, and Australia. Additional regulatory clearances are being pursued in other markets to expand access to Natural Cycles’ technology.
2 | UMass Amherst and Embr Labs Develop ‘Digital Drug’ to Predict Hot Flashes
Embr Labs, a Boston-based startup, and UMass collaborated to create a technology that predicts and alleviates hot flashes in menopausal women. They have developed a “reactive digital drug” wearable device that uses machine learning algorithms to predict hot flashes before they happen and provides cooling relief when needed. This approach is non-pharmaceutical and aims to provide personalized and automatic hot flash management. The technology has received support from grants, and previous pilot studies have shown positive results in sleep improvement and reduced frequency and intensity of hot flashes.
3 | Molina Healthcare Partners with Mae to Provide Pregnancy Support Digital Platform
Mae, a digital health platform offering support for Black expectant mothers postpartum and during pregnancy, announced that it will be partnering with Molina Healthcare of Virginia, a government-funded Medicare provider, to deliver these digital health offerings to Molina members at no cost. The partnership will also help connect women with virtual or community-based doulas who can provide birth education, emotional and lactation support, healing, and advocacy. The partnership is seen as an opportunity to address disparities in maternal health outcomes and the specific clinical and social needs of mothers.
4 | Maven Clinic and Amazon partner to offer fertility & family building support in 50 countries
Maven Clinic, a virtual women's health clinic, has partnered with Amazon to expand its family-planning support program to 50 countries outside the US and Canada. Through Maven, Amazon employees and their partners can access free family-planning care, including preconception support, egg freezing, IUI, and IVF. The partnership provides access to a wide range of healthcare providers, including reproductive endocrinologists, obstetricians, gynecologists, nutritionists, mental health providers, and adoption coaches. Virtual care is available through video or messaging in 35 languages, increasing accessibility of this digital health service.
5 | Visana Raises $10.1M Seed Round to Bring Comprehensive Virtual Healthcare to Women
Visana’s mission is to provide comprehensive clinical care for various women's health conditions, including endometriosis, fibroids, PCOS, contraception, UTIs, and menopause. They acknowledge that women's health solutions tend to focus on maternity and fertility, leaving out the majority of women who are not actively trying to build a family. Visana's virtual clinical care model has garnered support from investors who see its potential to significantly improve clinical outcomes and reduce costs for both employers and health plans. The company's goal is to transform the way women access and receive healthcare.
Midi Health, a virtual women’s health clinic specializing in perimenopause and menopause care, has closed a $25 million Series A funding round led by Google Ventures. By tailoring care plans, Midi Health offers holistic solutions, including hormonal and non-hormonal medications, evidence-based supplements, and integrative therapies. These initiatives aim to bridge gaps in women's health access, quality, and equity during the often challenging perimenopausal and menopausal transition. The company plans to utilize the new funding for nationwide expansion and partnership with major hospital systems and U.S. employers, and aims to deliver personalized, affordable, and accessible midlife care.
Informatics / Healthcare IT Solutions
Wolters Kluwer Health and Unbound Medicine have introduced a mobile app version of Lippincott's Nursing Drug Handbook, offering nurses a digital pocket guide with the latest FDA updates and information on over 3,800 drugs, including generics, brand names, and combinations. The app also features 300 pharmacology questions for nursing students preparing for the National Council Licensure Examination. This development aims to provide nurses with easy access to up-to-date drug safety information at the point of care, reducing the risk of medication errors.
2 | Teladoc Health Expands Collaboration in AI with Microsoft to Address Healthcare Workforce Crisis
Telehealth platform Teladoc Health is teaming up with Microsoft to incorporate AI solutions into its services, automating clinical documentation for virtual exams. The partnership integrates Microsoft Azure OpenAI Service, Azure Cognitive Services, and Nuance Dragon Ambient eXperience. This move aims to reduce administrative burdens on healthcare providers and enhance the doctor-patient relationship through AI technology. The announcement resulted in a stock price increase for Teladoc Health. The group will use Nuance DAX Express for efficient clinical documentation and coordinated care.
3 | Blue Shield of California partners with Microsoft for integrated data hub
Blue Shield of California has unveiled a multi-year cloud development plan in collaboration with Microsoft to introduce the Experience Cube, an integrated data hub powered by Microsoft's Azure cloud platform. This innovative platform will leverage Azure's analytics and storage capabilities to merge real-time data from members, providers, and payers. The goal is to offer more personalized healthcare services to members and provide valuable insights to healthcare providers. Initially, the Experience Cube will serve as an integrated digital health record, encompassing lab results, health conditions, medication details, plan coverage, and other pertinent healthcare information. Furthermore, the partnership aims to harness artificial intelligence and machine learning to meet the evolving needs of healthcare stakeholders. This initiative reflects a broader trend of Microsoft's growing presence and influence in the healthcare sector.
GE HealthCare has partnered with Mass General Brigham to create an AI algorithm designed to enhance scheduling predictions in healthcare. The algorithm, first applied to predict missed care opportunities, is integrated into the Radiology Operations Module (ROM), a digital imaging tool aimed at reducing costs and administrative burdens. By automating scheduling tasks, the collaboration seeks to free up healthcare providers to focus on patient care and interaction. Additionally, GE HealthCare recently introduced the smartphone-sized Portrait Mobile wireless monitoring solution, which received FDA clearance for in-hospital use to continuously monitor vital signs. These developments align with a broader trend of utilizing AI-driven scheduling systems to improve the quality and efficiency of healthcare.
California-based real-world data platform Atropos Health has successfully concluded a strategic financing round, with participation from investors including Sumitomo Corporation Venture Group's Presidio Ventures, Samsung Next, Audere Capital, and Gaingels. Atropos Health offers AI-powered innovations and clinical informatics services, including "Green Button" for rapid observational study reports. The company's platform helps physicians access real-world evidence for clinical decision-making and research. With the new funds, Atropos Health plans to expand globally, initially targeting customers in Brazil and Japan. This expansion aims to address the "evidence gap" caused by a lack of representation in clinical trials and provide more personalized evidence for healthcare decision-making worldwide.
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