Biofourmis’ BiovitalsHF to Augment Guideline-Directed Medical Therapy Receives FDA Breakthrough Device Designation

July 29, 2021—Biofourmis, a Boston, Massachusetts-based company focused in virtual care and digital therapeutics, announced that its BiovitalsHF solution, a heart failure digital therapeutic, receives a Breakthrough Device designation from the FDA.

BiovitalsHF, a software medical application used in combination with traditional pharmacotherapy, augments clinical decision-making with the goal of personalizing and improving the use and dose of guideline-directed medical therapy (GDMT) among patients with heart failure with reduced ejection fraction (HFrEF).

According to the company, the Biofourmis Care@Home platform enables clinicians to deliver personalized predictive care to patients outside of a traditional hospital or clinic across the continuum of care, including acute, postacute, and chronic care. Its Biovitals artificial intelligence-powered health analytics platform utilizes medical-grade wearables to continuously collect patient data to predict clinical exacerbation in advance of a critical event, thereby enabling earlier interventions for better clinical and financial outcomes.

The BiovitalsHF device integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management, and communication to provide clinicians with personalized and specific medication recommendations.

Biofourmis stated that the BiovitalsHF system alleviates some of the problems that prevent GDMT titration because of the following:

• It enables patient health status and drug tolerance to be accurately assessed through continuous physiology monitoring and inclusion of lab assessment results for analysis.
• It reduces clinical inertia by prompting clinicians and patients on medication initiation and up-titration.
• It reduces the burden of clinical visits through a patient-clinician communication system, which becomes essential in circumstances such as a pandemic.
• It requires less resources than nurse-led program because titration recommendations from the HFrEF management guidelines are distilled in the system.

The company noted that the FDA Breakthrough Devices program was created to provide patients and providers with timely access to medical devices by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization.