FDA selects Dexcom as first participant in TEMPO digital health pilot
The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digital health devices.
The pilot will evaluate Dexcom’s Glucose Health Program, which aims to support patients and caregivers in monitoring metabolic and nutritional status under the CMS Innovation Center’s ACCESS model for chronic disease care.
FDA officials said the program could provide real-world evidence to show how such technologies improve outcomes for the millions of Americans living with chronic conditions.
The collaboration with the CMS Innovation Center seeks to align device use with reimbursement pathways, potentially expanding coverage for effective digital health solutions.
This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot”
read at fda press ↗
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