Breakthrough Device Designation

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Pear claims breakthrough tag for alcohol use disorder DTx

Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorde

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FDA gives breakthrough status to Biofourmis' heart failure D...

A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis to be the first time the US regulator has gi

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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.

Pear claims breakthrough tag for alcohol use disorder DTx

FDA gives breakthrough status to Biofourmis' heart failure D...

FDA Breakthrough Device Designation for blood infection test

Sanofi drops BTK drug tolebrutinib in myasthenia gravis

How Moderna kept diversity in mind amid vaccine development

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Breakthrough Device Designation

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