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 […]<br /> This story continues at The Next Web [...]
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