Friday, March 16, 2018

FDA Breakthrough Device Designation for blood infection test

FDA Breakthrough Device Designation for blood infection test:

The FDA’s drive to accelerate access to new medical device technologies continues, with a new product from 3i Diagnostics receiving a Breakthrough Device Designation.
While the US regulator first launched the similar Breakthrough Therapy Designation for innovative medicines six years ago, the similar fast-track for devices was formalised in late 2017.

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