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# ‘Breakthrough’ for Biofourmis Heart Software
- URL: https://www.fdaweb.com/breakthrough-for-biofourmis-heart-software/
- Published: 2021-08-02T12:00:00.000Z
- Updated: 2026-09-14T17:08:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149842

FDA has granted Biofourmis a breakthrough device designation for BiovitalsHF, a software medical application that is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy.

It specifically is designed to assist with guideline-directed medical therapy in patients with heart failure with reduced ejection fraction, the company says. “The device integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management, and communication to provide clinicians with personalized and specific medication recommendations,” it says.