Posted by Michael Wonder on 29 Jul 2021
Biofourmis earns FDA's first ever breakthrough device designation for a novel digital therapeutic for heart failure
29 July 2021 - BiovitalsHF approved for expedited FDA review process as a first-in-class digital therapeutic for heart failure that augments traditional guideline-directed medical therapy.
Biofourmis announced today its BiovitalsHF solution is the first-ever heart failure digital therapeutic to receive a breakthrough device designation from the U.S. FDA.
