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FDA Press Releases·

FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot

The U.S. Food and Drug Administration today 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.“For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing,” said Center for Devices and Radiological ...