BOSTON, Oct. 3, 2019 /PRNewswire/ -- 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."
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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. The newly cleared Analytics Engine is a much broader approval to process multiple physiology signals, as the technology serves as the foundation for all of Biofourmis' digital therapeutics product pipeline.
"The Biovitals™ Analytics Engine helps to fill a critical unmet medical need in heart failure care," said Raj Khandwalla, MD, MA, Assistant Professor at the Cedars-Sinai Smidt Heart Institute, Director of Cardiovascular Education at the Cedars-Sinai Care Foundation, and Biofourmis Clinical Advisory Board member. "Numerous studies consistently demonstrate that guideline-directed medical therapy is underutilized in patients with heart failure, which is likely the reason that historic decreases in morbidity and mortality have not only plateaued, but have unfortunately begun to increase. The Biovitals™ Analytics Engine within the context of the BiovitalsHF™ platform will likely lead to improved clinical outcomes."
An Important Tool in the Move to Value-Based Care
The Biovitals™ Analytics Engine receives physiologic data such as heart rate, respiratory rate and activity in near real-time from FDA-cleared sensors and leverages AI and machine learning to identify the correlation between multiple vital signs and the patient's daily activities, building an individualized biometric signature that is dynamically updated based on incoming data. The Biovitals™ Analytics Engine computes a time series Biovitals™ Index, which alerts providers to changes in patients' measured vital signs from their baseline—a precursor to decompensation that in some cases may be up to a few weeks before an event would have occurred without any intervention. This advance notice provides ample time for the clinician to take the necessary clinical steps to change the trajectory of the disease.