FDA announces first company to participate in health tech pilot
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Under the TEMPO pilot program, Dexcom can receive Medicare reimbursement when seniors receive care from their software.
The Food and Drug Administration announced Wednesday that Dexcom’s glucose monitoring software that offers patients artificial intelligence-powered health guidance is the first to be selected for the Technology-Enabled Meaningful Patient Outcomes — or TEMPO — program.
“The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them,” Michelle Tarver, head of FDA’s medical device center, said in a press release.
Dexcom, a multinational health care company, said in a separate release that its technology combines data from its G7 and Stelo sensors with additional health information such as sleep, nutrition and stress to offer personalized health insights.
With all of that data, the company also plans to give health care practitioners and technology users a comprehensive view of metabolic health that will help control patients’ blood sugar levels.
“Transforming [glucose] 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,” Jake Leach, president and CEO of Dexcom, said in the release.
Other health software developers are working with FDA to participate in TEMPO, which plans to allow up to forty technologies to enjoy a reprieve from certain medical device regulations and Medicare payments when doctors get seniors to use them. Those payments are enabled by a CMS Innovation Center program known as the Advancing Chronic Care with Effective, Scalable Solutions — or ACCESS — model.
The TEMPO and ACCESS initiatives are designed to encourage seniors to use technology that will tangibly improve their diabetes, hypertension, chronic pain, depression and other serious health conditions. The ACCESS model launched on July 5 with companies promising to offer seniors everything from AI-generated food recommendations to guided meditation lessons.