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,