Home » Biofourmis Gets FDA Breakthrough Device Designation for Heart Failure Device
Biofourmis Gets FDA Breakthrough Device Designation for Heart Failure Device
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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