Digital health company Biofourmis has secured a prestigious breakthrough device designation from the FDA. Its BiovitalsHF software, an application designed to assist with the medical therapy needs of patients with heart failure, will make history as the first HF digital therapeutic to earn this designation.
The device integrates guideline-directed medical therapy, which in this case entails symptom reporting, patient engagement, medication management, and physiological monitoring. It gives providers a throughline to initiating guideline-recommended and lifesaving medical therapies for HF patients with diminished ejection fraction. A proof-of-concept study showed that BiovitalsHF treatment led to health status stabilization, with success in adherence to GDMT and decreased levels of HF blood indicator N-terminal pro-B type natriuretic peptide.
In that initial study, 282 patients were given BiovitalsHF and monitored for three months. Their results were then compared with those of traditionally-treated patients to ascertain whether the platform could optimize medical dosage by getting patients within 50% of optimal dose.
True FDA approval may be around the bend for BiovitalsHF, as breakthrough devices automatically receive priority FDA review. The designation gives FDA personnel early access to the software in order to streamline the review and approval procedure. Regardless, Biofourmis will need to undergo additional rounds of testing to further prove efficacy.