US FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
United States, July 22 -- The U.S. Food and Drug Administration announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center's ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model and intended to improve health outcomes for Americans managing certain chronic diseases. The FDA selected Dexcom, Inc., as the first participant in the TEMPO pilot. The Dexcom Glucose Health Program, which the FDA will continue to evaluate for its intended use during the pilot, is intended to ...
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