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Highlights & Summary
2025 is off to a strong start with exciting digital health news! Read more here:
In Disease Management and Digital Therapeutics, PanopticAI received FDA 510(k) clearance for its AI-powered mobile app that measures pulse rate contactlessly using an iPhone or iPad camera, making it the first Hong Kong-based company to achieve this milestone. Meanwhile, the FDA issued a Class I recall for Philips’ Mobile Cardiac Telemetry Monitoring service due to software issues that caused missed alerts, leading to two deaths and over 100 reported injuries.
In Informatics and Healthcare IT, AWS partnered with General Catalyst to develop AI-powered healthcare solutions focused on predictive care and operational efficiency. Ascend Medical and Amenities Health launched a mobile diagnostics platform integrating digital registration and appointment scheduling with AthenaOne EHR, improving patient workflows. Additionally, Century Health partnered with Nira Medical to leverage AI-driven EHR data curation, enhancing research and treatment for multiple sclerosis. Innovaccer secured $275 million in Series F funding to expand its AI-powered healthcare data analytics and value-based care solutions.
In Women’s Health and Femtech, Teal Health raised $10 million to advance its FDA-reviewed Teal Wand™, an at-home cervical cancer screening device designed to improve screening accessibility and adherence. Allara Health secured $26 million in Series B funding to expand virtual care for women with hormonal conditions such as PCOS and endometriosis, strengthening insurance partnerships and clinical expertise to bridge gaps in women’s healthcare.
Disease Management / Digital Therapeutics
1 | Mobile contactless pulse rate monitoring app receives FDA 510(k)
2 | FDA elevates Philips recalls mobile cardiac telemetry device over missed alerts, following 2 deaths
Informatics / Healthcare IT Solutions
1 | Amazon Web Services partners with General Catalyst to develop healthcare IT tools
2 | Ascend Medical partners with Amenities Health to launch mobile diagnostics and virtual care services
4 | Innovaccer secures $275M to scale its healthcare intelligence cloud
Women’s Health / Femtech
2 | Allara Health raises $26 million in Series B funding for women's hormonal healthcare
Disease Management / Digital Therapeutics
1 | Mobile pulse rate monitoring app receives FDA 510(k)
PanopticAI has received FDA 510(k) clearance for PanopticAI Vital Signs, a mobile app that measures pulse rate contactlessly using the built-in camera of iPhones and iPads. This makes PanopticAI the first Hong Kong-based company to get FDA clearance for a software as a medical device. The app uses advanced AI and photoplethysmography algorithms to analyze skin color changes captured by the device’s camera, enabling accurate pulse rate measurement in just 30 seconds. The app was tested for accuracy across diverse patient populations and real-world conditions, including different lighting and distances, and also underwent cybersecurity and user safety testing. This breakthrough reduces the need for specialized medical equipment, offering a cost-effective, scalable solution for vital sign monitoring.
2 | FDA elevates Philips recalls mobile cardiac telemetry device over missed alerts, following 2 deaths
The FDA has elevated a recall from Philips regarding its wearable outpatient heart monitor, used to detect transient arrhythmias, such as atrial fibrillation and ventricular tachycardia. The issue involves incorrect flagging of certain cardiac events by the monitor's software, preventing timely review by clinicians. The FDA has classified the recall as Class I, the most serious type, as it has been linked to 109 injuries and 2 deaths. Philips has notified healthcare providers using its Mobile Cardiac Telemetry Monitoring service (MCOT) and BTPS-1000 wearable patch, offering them the ability to reprocess and reanalyze affected ECG reports. The FDA estimates that around 130,000 MCOT patches have been distributed in the U.S. to over 41,200 customers. Philips has stated that the service is now functioning normally.
Informatics / Healthcare IT Solutions
1 | Amazon Web Services partners with General Catalyst to develop healthcare IT tools
Amazon Web Services and General Catalyst are collaborating to develop AI-powered healthcare solutions aimed at improving predictive care, interoperability, operational efficiency, and patient engagement. The partnership will leverage Amazon Bedrock, Anthropic, and Mistral AI, alongside healthcare-specific models, to deploy scalable and secure AI applications.
AWS will provide cloud infrastructure and AI expertise, while General Catalyst portfolio companies like Commure and Aidoc will integrate their Copilot Suite and aiOS technologies to enhance AI-driven workflows. “Together, we are embedding AI throughout the care journey to improve patient outcomes,” said AWS CEO Matt Garman.
This alliance follows General Catalyst’s $8 billion fundraise in 2023 and its push to scale AI-driven healthcare innovations globally.
2 | Ascend Medical partners with Amenities Health to launch mobile diagnostics and virtual care services
Amenities Health has partnered with Ascend Medical to enhance digital healthcare access through a white-labeled mobile app. Powered by Amenities Health’s API and deep link integration with AthenaOne EHR, the app enables Ascend Medical patients to complete digital registration in under 60 seconds and schedule appointments based on availability and proximity.
This collaboration enhances care coordination by simplifying patient intake and streamlining workflows, improving efficiency from initial contact to follow-up. “The platform we've developed together allows for an effortless, intuitive experience akin to today’s best-in-class consumer applications,” said Aasim Saeed, Founder and CEO of Amenities Health. The integration highlights how digital convenience can enable personalized care.
Century Health and Nira Medical have announced a partnership to leverage AI-driven data curation for more than 3,000 multiple sclerosis patients, unlocking real-world insights into treatment and outcomes. By integrating with EHR systems, Century Health’s HIPAA-compliant platform will transform unstructured clinical data into curated datasets to support research and accelerate drug development in collaboration with life sciences companies.
"This partnership enables us to efficiently transform raw, unstructured data into actionable insights," said Rebekah Foster, Head of Data at Nira Medical. The initiative aims to improve MS patient care, generate insights into disease progression and treatment effectiveness, and expand access to new therapies.
4 | Innovaccer secures $275M to scale its healthcare intelligence cloud
Health data analytics firm Innovaccer secured $275 million in Series F funding, bringing total funding to $675 million. The investment will enhance its AI and cloud capabilities, expand its developer ecosystem, and improve value-based care solutions. Innovaccer’s Healthcare Intelligence Cloud streamlines workflows, reduces administrative burden, and enhances patient engagement. The company plans to introduce AI-powered copilots for clinical decision support, prior authorization, and care management. "This funding will enable us to push the boundaries of what’s possible in healthcare AI," said CEO Abhinav Shashank.
Women’s Health / Femtech
Teal Health has secured $10 million in seed funding, bringing its total funding to $23 million, to support the launch of the Teal Wand™, an FDA-reviewed at-home cervical cancer screening device. This investment builds on the company’s recent milestones, including FDA Breakthrough Device Designation and a grant awarded by the National Cancer Institute. The Teal Wand aims to increase screening rates by providing a more convenient and user-friendly alternative to traditional cervical cancer screening methods, aligning with recent recommendations recognizing the effectiveness of self-collection. With investor backing and growing clinical support, Teal Health aims to transform cervical cancer screening accessibility and adherence in the U.S.
2 | Allara Health Raises $26 Million in Series B Funding for Women's Hormonal Healthcare
Allara Health has raised $26 million in a Series B funding round, bringing its total funding to nearly $40 million. The company provides virtual, specialized care for women with chronic hormonal conditions such as PCOS, endometriosis, and hypothyroidism, addressing a significant gap in diagnosis and treatment. In 2024, Allara expanded its services nationwide, partnered with major insurers, and appointed a new CMO to enhance its clinical expertise. With its whole-body approach and expert-led care plans, Allara aims to improve patient outcomes and improve access to women’s hormonal health care via telemedicine, digital health coaching, and remote patient monitoring.
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