Biofourmis Earns FDA Breakthrough Device Designation for Digital Therapeutic for Heart Failure

– Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).

– The Breakthrough Devices Program was created to provide patients and providers with timely access to medical devices (in this case, software as a medical device, or SaMD) by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, according to the FDA.