The FDA just picked its first company to sell an unauthorised device to Medicare patients
The US Food and Drug Administration named Dexcom as the first manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes pilot on Tuesday. The programme, known as TEMPO, allows digital health devices to be offered to Medicare patients before the agency has authorised them for that use.
The mechanism is enforcement discretion. Rather than granting approval, the FDA agrees not to enforce premarket authorisation requirements for participating devices, provided manufacturers collect and share real-world data on how those devices perform in practice.
What Dexcom is offering
The Dexcom Glucose Health Program will address two clinical use areas within the Centers for Medicare and Medicaid Services ACCESS model. It is intended to let patients and their clinicians monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for behavioural changes.
The FDA describes the programme as an aid in screening for prediabetes and type 2 diabetes through...
Copyright of this story solely belongs to thenextweb.com. To see the full text click HERE
