Get the latest news in health technology, digital health and health AI with this weekly overview. News for the week from July 20th to 24th.
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 the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model for uncleared devices. This program aims to evaluate new regulatory approaches to specific 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 provides stable, recurring payments for technologies used to treat diabetes, hypertension, chronic kidney disease, obesity, depression, and anxiety when certain clinical outcomes are met.
In most cases, devices used to treat chronic conditions must be reviewed by the FDA and cleared for use. The new TEMPO pilot gives the agency enforcement discretion for devices in the ACCESS program that have not yet undergone FDA’s premarket approval process.
Through TEMPO, Dexcom, a manufacturer of continuous blood glucose monitors, is implementing an AI-powered blood glucose health program that integrates data from the Dexcom G7 and Stelo with contextual health information such as nutrition, physical activity, sleep, and stress, providing more personalized insights for healthcare professionals and program users. The program also aims to support screening for prediabetes and type 2 diabetes through integrated digital health metrics, which may contribute to improved blood sugar control and lower HbA1c in prediabetic patients, the medical device company said.
The pilot will support Dexcom’s efforts to generate real-world evidence to evaluate how glucose biosensing technology and AI-enabled digital health programs advance early intervention strategies, including research focused on prediabetes and type 2 diabetes, as well as future efforts to gather evidence on broader cardiometabolic health outcomes, the company said.
“Glucose is one of the body’s most powerful health signals, providing instant insight into a person’s overall health,” Jake Leach, president and CEO of Dexcom, said in a statement. “Translating this data into more personalized, proactive screening and preventive care has the potential to help millions of people make meaningful lifestyle changes before disease onset. It will also generate the evidence needed to expand access to these technologies. Being the first company selected by the FDA to participate in this pilot program is another first for Dexcom and underscores our continued leadership in innovation.”
The FDA plans to select up to approximately 10 TEMPO pilot participants in each of the four U.S.-based ACCESS model clinical use areas, reflecting a wide range of manufacturers, the FDA said. The agencies say the TEMPO pilot will help FDA and CMS better understand how digital health technologies work in real-world settings and how they can support efforts to improve care for people living with chronic conditions.
Ardent Health Ambient AI successfully reaches over 1 million patients
Brentwood, Tennessee-based Ardent Health announced Thursday that Ambience Healthcare’s ambient AI platform has surpassed 1 million patient interactions.
According to Ardent Health, Ardent-affiliated clinicians with access to Ambience’s ambient AI tools use the technology in 87% of outpatient visits across specialties, a rate significantly higher than industry benchmarks of approximately 40-45% reported in peer-reviewed independent studies. “This milestone not only reflects high utilization rates, but also demonstrates how Ardent is integrating ambient AI into daily clinical workflows, saving providers an average of more than three hours per week on documentation, according to EHR data,” said health system executives.
The technology was first rolled out enterprise-wide in September.
“Reaching 1 million visits is a testament to physicians and advanced practice providers who have embraced this technology as a way to spend less time on documentation and more connections with patients,” said Dr. Brad Hoyt, chief medical information officer at Ardent Health, in a statement. “Ambience reduces administrative burden and helps combat clinician burnout, allowing providers to be more present during visits, strengthening patient-provider relationships, and improving the care experience.”
Dr. Jenny Zheng, a family medicine physician at UT Health East Texas in Tyler, Texas, uses Ambience for 83% of her visits and reports a 53% reduction in EHR documentation time from 135 minutes to 64 minutes per eight-hour appointment.
“One of the most important things a doctor can do is really listen,” says Zheng. “Technology often creates barriers between healthcare providers and patients because so much of our attention is focused on documentation.”
She added, “Ambience allows us to spend more time listening carefully and engaging with our patients and their families. In communities like the East Texas we serve, strong relationships and trust are critical, and that special attention makes a big difference.”
Thrive Mobile, HealthEx Partner Expands Access to Medical Records
Healthcare platform HealthEx has partnered with Thrive Mobile, the first wireless provider built to improve health outcomes for underserved Americans, to improve access to medical records.
The partnership will give users access to their medical records directly from their smartphones and will allow members to share their records and receive a QR code for their medical records through a simple and secure process.
Members can choose whether to connect their records and see what information is shared where. Additionally, you can stop sharing your recordings at any time.
“Patients with the least financial means are often asked to shoulder the greatest burden of care navigation,” HealthEx CEO and co-founder Priyanka Agarwal said in a statement. “Patients are already overrepresented on Medicaid due to income, ZIP code, and digital access, and the system requires patients to track their medical records across scattered providers. Thrive and HealthEx consolidate disconnected records and store them on the devices they already have at hand.”
The companies say the partnership will begin with a pilot group of “initial health insurance enrollees,” with broader availability expected in early 2027.
VitVio launches access to 3D native AI operating room intelligence platform
VitVio announced Thursday that its 3D native AI platform for operating room intelligence is now available to hospitals and health systems around the world, including the United States.
The platform, called Vetro, uses a multi-camera system with ambient sensing and computer vision to continuously feed 3D to VitVio’s spatial context engine. This combined with live spatial maps provides a live recording of the operating room.
Executives say it is the “first and only system of its kind in the world.”
“We spent two years building Vetro to operate under real pressure in real operating rooms,” VitVio CEO and co-founder Thomas Knox said in a statement. “Now is the time to bring the impact our early partners have seen to hospitals and health systems around the world.”
AdvancedMD expands RCM offering powered by Waystar AI
AdvancedMD, a cloud-based healthcare software provider, announced Wednesday the expansion of its revenue cycle offering powered by Waystar.
New features include coverage discovery, denial and appeal management, and paper-to-electronic EOB conversion and analysis.
AdvancedMD CEO Amanda Sharp said in a statement: “Our goal is to help healthcare providers and their staff improve their daily workflows and prioritize patient care over paperwork. Having access to these Waystar capabilities gives our customers access to effective solutions that not only help improve their claims and payment processes, but also positively impact their bottom line. This is another way AdvancedMD is advancing healthcare. It provides healthcare providers with the tools they need to implement their practices without delay.”
Headspace announces four partnerships to expand specialty care delivery
Mental health platform Headspace is expanding its specialty care offerings through four new partnerships announced Tuesday.
Headspace members can now refer Charlie Health to our virtual intensive outpatient program. Cortica is for children 17 and under with autism spectrum disorder (ASD) and other neurodevelopmental disorders. Prosper Health offers telehealth assessments and Equip supports eating disorder patients.
Referrals can be made through Headspace therapists, psychiatrists, and coaches if clinically appropriate.
“Families seeking autism evaluation, eating disorder treatment, or intensive outpatient therapy are often going through the most difficult times in their lives. They need a clear path to care, not a complicated search process,” Headspace Chief Clinical Officer Dr. Jenna Glover said in a statement. “People are at different stages and need different types of support, whether it’s daily stress or sleep support or more advanced clinical care. These partnerships allow us to meet members wherever they are and connect them to the right level of care more quickly, allowing us to better support some of the most prevalent and underserved needs in today’s patient population.”
