Stay up to date on the latest in health tech, digital health and health AI news with this weekly brief. This is news from the week of July 20-24.
FDA selects Dexcom as first participant in TEMPO digital health pilot
The U.S. Food and Drug Administration (FDA) this week named Dexcom as the first digital health device company to participate in the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program. TEMPO is designed to evaluate digital health technologies that improve chronic disease management while generating real-world evidence.
The Trump administration introduced TEMPO last year as a companion program to its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model for uncleared devices. The program aims to evaluate a new regulatory approach for certain digital health technologies that support chronic disease management while collecting real-world performance data.
The first cohort of the ACCESS model launched earlier this month and the program offers stable, recurrent payment for technology used to treat diabetes, hypertension, chronic kidney disease, obesity, depression and anxiety that meets certain clinical outcomes.
In most cases, devices used to treat chronic conditions would have to undergo review by the FDA and be cleared for that use. The new TEMPO pilot allows the agency to offer enforcement discretion to devices in the ACCESS program that have not yet undergone the FDA premarket authorization process.
Through TEMPO, Dexcom, which makes continuous glucose monitors, will implement an AI-powered glucose health program that integrates data from Dexcom G7 and Stelo with contextual health information such as nutrition, physical activity, sleep and stress, to deliver more personalized insights for healthcare professionals and program-eligible users. The program is also intended as an aid in the screening of prediabetes and Type 2 diabetes through integrated digital health metrics and may contribute to improving glycemic control and lowering HbA1c in people with prediabetes, the medical device company said.
The pilot will support Dexcom's efforts to generate real-world evidence evaluating how glucose biosensing technology and AI-enabled digital health programs advance earlier intervention strategies, including research focused on prediabetes and Type 2 diabetes, and future efforts to collect evidence for broader cardiometabolic health outcomes, the company said.
"Glucose is one of the body's most powerful health signals, providing immediate insight into a person’s overall health,” said Jake Leach, president and CEO of Dexcom, in a statement. “Transforming this data into more personalized, proactive screening and preventive care has the potential to help millions of people make meaningful lifestyle changes before disease develops, while also generating the evidence needed to expand access to these technologies. Being the first company selected by the FDA to participate in this pilot program marks another first for Dexcom and underscores our continued leadership in innovation."
The FDA plans to select up to about ten TEMPO pilot participants in each of four ACCESS model clinical use areas who reflect a broad spectrum of manufacturers and are based in the U.S., the agency said. The TEMPO pilot will help the FDA and CMS better understand how digital health technologies perform in real-world settings and how they may support efforts to improve care for people living with chronic diseases, according to the agencies.
Ardent Health ambient AI hits more than 1 million patient encounters
Brentwood, Tenn.-based Ardent Health announced Thursday its Ambience Healthcare ambient AI platform has surpassed more than one million patient interactions.
Ardent-affiliated clinicians with access to Ambience's ambient AI tool use the technology in 87% of ambulatory encounters across specialties, a rate that significantly exceeds industry benchmarks of roughly 40% to 45% reported in peer-reviewed and independent studies, according to Ardent Health. "The milestone reflects more than high utilization; it demonstrates how Ardent is integrating ambient AI into everyday clinical workflows, with providers saving an average of more than three hours per week in documentation time, according to EHR data," health system executives said.
The technology was first deployed enterprise-wide in September.
“Reaching a million encounters is a testament to our physicians and advanced practice providers who have embraced this technology as a way to spend less time documenting and more time connecting with patients,” said Brad Hoyt, M.D., Ardent Health chief medical information officer, in a statement. “By reducing administrative burden and helping combat clinician burnout, Ambience allows providers to be more present during visits, strengthening the patient-provider relationship and enhancing the care experience.”
Jennie Zheng, M.D., a family medicine physician with UT Health East Texas in Tyler, Texas, reports using Ambience for 83% of her encounters and has reduced her EHR documentation time by 53%, from 135 minutes to 64 minutes per eight hours of appointments.
"One of the most important things a physician can do is truly listen," Zheng said. "Technology often creates barriers between providers and patients because so much of our attention is focused on documentation."
She added, "With Ambience, I’m able to spend more time listening carefully and engaging with patients and their families. For communities like those we serve in East Texas, where strong relationships and trust are so important, that extra attention makes a real difference.”
Thrive Mobile, HealthEx partner to expand health record access
Health platform HealthEx is partnering with Thrive Mobile, the first wireless provider built to improve health outcomes for underserved Americans, to improve access to medical records.
The partnership will allow users to directly access health records from their smartphones, with members being able to share their records through a simple, secure process and receive a medical record QR code.
Members have the choice whether to connect records and see what information is shared and where. Moreover, they can stop sharing records at any time.
“The patients who can least afford to are often the ones asked to bear the greatest burdens of care navigation,” said Priyanka Agarwal, HealthEx CEO and co-founder, in a statement. “Income, zip code, and digital access already stack the odds against patients on Medicaid, and the system leaves these patients to track down health records across scattered providers. Thrive and HealthEx unify their disconnected records and put them right on the device already in their hand.”
The partnership will kick off with a pilot group within a “first health-plan population,” with broader availability expected in early 2027, the companies say.
VitVio launches access to 3D-native AI operating room intelligence platform
VitVio announced Thursday its 3D-native AI platform for operating room intelligence is now available for hospitals and health systems around the globe, including in the U.S.
The platform—dubbed Vetro—uses a multi-camera system with ambient sensing and computer vision to continuously provide 3D to VitVio’s Spatial Context Engine. This, combined with live spatial maps, provides a live record of operating rooms.
Executives say it is the “world’s first and only” system of its kind.
"We've spent two years building out Vetro to work under real pressure, in real operating rooms,” said Thomas Knox, VitVio CEO and co-founder, in a statement. “Now it's time to bring the impact our early partners are seeing to hospitals and health systems around the world.”
AdvancedMD expands Waystar AI-powered RCM offerings
Cloud-based healthcare software provider AdvancedMD announced Wednesday an expansion of its Waystar-powered revenue cycle offerings.
Among the new capabilities are coverage detection, denial and appeal management, paper-to-electronic EOB conversion and analytics.
“As a leading provider of healthcare office software for independent practices, we know the struggles and friction our customers face day to day,” said Amanda Sharp, AdvancedMD CEO, in a statement. “Our goal is to help providers and their staff improve daily workflows so they can prioritize patient care over paperwork. With the availability of these Waystar capabilities, our customers gain access to effective solutions that not only help improve claims and payment processes, but also positively impact their bottom line. It’s one more way AdvancedMD moves care forward, giving providers the tools they need to practice their way—without delay.”
Headspace announces four partnerships to expand specialty care offerings
Mental health platform Headspace is expanding its specialty care offerings through four new partnerships announced Tuesday.
Headspace members can now be referred to Charlie Health for virtual intensive outpatient programs; Cortica for children 17 and under with autism spectrum disorder (ASD) and other neurodevelopmental conditions; Prosper Health for telehealth evaluations and Equip for patients with eating disorders.
Referrals can be made through Headspace therapists, psychiatrists and coaches when clinically appropriate.
“Families seeking autism evaluations, eating disorder treatment, or intensive outpatient care are often navigating some of the hardest moments of their lives. They deserve a clear path to care, not a confusing search process,” said Jenna Glover, Ph.D, Headspace chief clinical officer, in a statement. “People are at different stages and need different kinds of support, whether that’s for everyday stress and sleep support, or higher-acuity clinical care. These partnerships help us meet members wherever they are and connect them to the right level of care faster, providing better support for some of the most prevalent and underserved needs in today's patient population.”