Latest / Medical Device Global Market Access
FDA's 2026 TEMPO Pilot: The Bridge to Reimbursement for Digital Health?
This episode delves into the U.S. FDA's upcoming Total Product Life Cycle (TPLC) Advisory Program, known as TEMPO, set to launch in 2026. We explore its potential to revolutionize the pathway for digital health and chronic-care medical devices by integrating payers early in the regulatory process. We analyze whether TEMPO can successfully bridge the gap between regulatory approval and reimbursement, or if manufacturers will still face significant hurdles in proving value to secure market access. - What is the FDA's TEMPO pilot program launching in 2026? - How does TEMPO aim to connect…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.