Biofourmis: breakthrough designation for digital therapy
Digital therapeutics firm Biofourmis has announced its BiovitalsHF heart failure digital therapeutic is the first such item to receive Breakthrough Device designation from the US Food and Drug Administration (FDA). Biovitals HF is a software application that augments guideline-directed use of medications to manage patients, in combination with traditional pharmacotherapy.
“This important breakthrough designation will help accelerate FDA’s final review of BiovitalsHF,” said Kuldeep Singh Rajput, CEO and founder of Biofourmis. “If approved at the end of this expedited process, we look forward to introducing a new virtual HF Care model that leverages the BiovitalsHF digital therapeutic to improve the use and dosing of Guideline-Directed Medical Therapy among patients with heart failure, for better patient outcomes and reduced healthcare expenditures.”
