Biofourmis' Biovitals Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring

Biofourmis, a fast-growing global leader in digital therapeutics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. This regulatory approval of the Biovitals Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category. "This milestone approval is foundational to the Biovitals ecosystem, which includes not only our most advanced solution, BiovitalsHF for heart failure--but also our range of solutions across therapeutic areas, such as pain, oncology, sleep disorders and others in development," said Kuldeep Singh Rajput, CEO and founder of Biofourmis. "Receiving this important regulatory approval will only accelerate the development and commercialization of these innovative digital therapeutic solutions." This FDA approval is the second market authorization for Biofourmis, having earned the agency's approval in May 2019 for its Biovitals RhythmAnalytics platform, which is cloud-based software for automated interpretation of more than 15 types of cardiac arrhythmias.