Software to guide medical therapy in HF earns FDA breakthrough device designation
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Biofourmis announced that its software application to help manage medical therapy in patients with HF has received a breakthrough device designation from the FDA.
The software (BiovitalsHF) is the first HF digital therapeutic to receive the designation, according to a press release from the company.
The device was designed to promote use of guideline-directed medical therapy (GDMT) in patients with HF by integrating physiological monitoring, reporting of signs and symptoms, patient engagement, medication management and communication, according to the release, which stated that the goal is to provide clinicians with personalized, specific medication recommendations.
“The BiovitalsHF digital therapeutic is a software medical application that enables providers to rapidly initiate and intensify lifesaving and guideline-recommended medical therapies for patients with heart failure with reduced ejection fraction in a way that is nearly automated,” Maulik Majmudar, MD, cardiologist and chief medical officer and co-founder of Biofourmis, said in the release. “In a proof-of-concept study, in patients using BiovitalsHF, we demonstrated statistically significant improvements in adherence to GDMT; reduction in levels of the key blood biomarker of HF N-terminal pro-B type natriuretic peptide; and improvements in health status.”
Breakthrough devices receive priority FDA review; the designation allows early interaction with FDA personnel to expedite the review and approval process.
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