Biofourmis has secured breakthrough device status from the US Food and Drug Administration (FDA) for its BiovitalsHF digital therapeutic to treat heart failure.

BiovitalsHF is claimed to be the first of its kind digital heart failure treatment to receive FDA breakthrough device designation.

The new software medical application will enable to boost the guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy.

Biofourmis chief medical officer and co-founder Dr Maulik Majmudar said: “The BiovitalsHF digital therapeutic is a software medical application that enables providers to rapidly initiate and intensify life-saving and guideline-recommended medical therapies for patients with heart failure with reduced ejection fraction in a way that is nearly automated,”

BiovitalsHF is developed to support decision-making to personlaise and improve the use and dose of Guideline-Directed Medical Therapy (GDMT) among patients with heart failure with reduced ejection fraction (HFrEF).

The digital therapeutic incorporates physiological monitoring, symptoms and signs reporting, patient engagement, medication management, and communication to deliver personalised and specific medication recommendations to clinicians.

BiovitalsHF allows to precisely assess patient health status and drug tolerance via continuous physiology monitoring and inclusion of lab assessment results for analysis.

The device minimises clinical inertia by prompting clinicians and patients on medication initiation and up-titration. Its patient-clinician communication system enables to minimise the burden of clinical visits.

Biofourmis CEO and founder Kuldeep Singh Rajput said: “This important breakthrough designation will help accelerate FDA’s final review of BiovitalsHF.

“If approved at the end of this expedited process, we look forward to introducing a new virtual heart failure 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.”

In September last year, Biofourmis received a $100m series C financing to accelerate its US and global expansion efforts.