Biofourmis receives FDA breakthrough device designation for heart failure “digital therapy”

Kuldeep Singh Rajput, the founder of Boston-based Biofourmis, is imagining a future where heart failure patients go home with a prescription, a wearable sensor and an app. Today, a new FDA designation gets the company one step closer to that goal. 
Founded in 2015, Biofourmis is a digital therapeutics company that develops software to “augment” patient care. So far, the company has raised about $145 million in funding, and has around 350 employees, Rajput estimates. 
On Thursday, Biofourmis BiovitalsHF, a platform designed for heart failure medication monitoring received an FDA breakthrough device designation. Breakthrough device designation doesn’t signal FDA clearance, but it does allow for an expedited review process, and gives the company access to expertise from the federal agency during development. 
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