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Breakthrough Status

Biofourmis Gets FDA Breakthrough Device Designation for Heart Failure Device

July 30, 2021

Boston-based Biofourmis has received the FDA’s Breakthrough Device designation for its BiovitalsHF medical device software for treatment of heart failure.

The artificial intelligence-based software is intended to augment traditional guideline-directed use of heart failure drugs.

The application enables providers to rapidly initiate life-saving medical therapies for patients with heart failure with reduced ejection fraction “in a way that is nearly automated," according to Maulik Majmudar, the company’s chief medical officer and co-founder.

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