Story thread · 3 reports / 3 sources

The FDA just picked its first company to sell an unauthorised device to Medicare patients

thenextweb.com · 15d

The FDA just picked its first company to sell an unauthorised device to Medicare patients

How the coverage leans

Across 3 sources · syndicated copies counted once

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 […] This story continues at The Next Web

First report: FDA selects 1st digital health device pilot participant beckershospitalreview.com, 15d

The coverage

  1. FDA announces first company to participate in health tech pilot

    nextgov.com · 15d

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