Medical therapy

Software to Guide Medical Therapy in CI Earns FDA Breakthrough Device Designation


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Biofourmis announced that its software application to help manage medical treatment in patients with HF has received Breakthrough Device Designation from the FDA.

The software (BiovitalsHF) is the first digital HF therapeutic to receive the designation, according to a company press release.

FDA headquarters in Washington
Source: Adobe Stock

The device was designed to promote the use of guideline-directed medical therapy (GDMT) in patients with HF by integrating physiological monitoring, sign and symptom reporting, patient engagement, medication management and communication, according to the release, which said the goal is to provide clinicians with personalized and specific medication recommendations.

Maulik Majmudar

“BiovitalsHF Digital Therapeutics is a software-based medical application that enables providers to rapidly initiate and scale up vital, guideline-recommended medical therapies for heart failure patients with reduced ejection fraction in a way almost automated”, Maulik Majmudar, MD, cardiologist and chief medical officer and co-founder of Biofourmis, said in the statement. “In a proof-of-concept study, in patients using BiovitalsHF, we demonstrated statistically significant improvements in adherence to GDMT; reduced levels of the key blood biomarker N-terminal pro-B-type natriuretic peptide HF; and improving health status.

Breakthrough devices receive priority FDA review; the designation allows for early interaction with FDA staff to expedite the review and approval process.