Biofourmis received approval from the U.S. Food and Drug Administration (FDA) for its Biovitals™ Analytics Engine in May 2019.
Digital therapeutics company, Biofourmis, 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, a cloud-based software for automated interpretation of over 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 receives physiologic data 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. The Biovitals™ Analytics Engine computes a time series Biovitals™ Index, which reflects and alerts providers to changes in patients measured vital signs from their baseline. This advance notice provides ample time for the clinician to take the necessary clinical steps to change the trajectory of the disease.
In addition to benefitting patients, the Biovitals™ platform can potentially reduce hospital readmissions and decreases the need for emergency department (ED) visits.
“As the healthcare industry transitions to risk-bearing, value-based care models, tools such as the Biovitals™ Analytics Engine are essential to efficiently and effectively monitor and detect changes in patients’ health status before an adverse event leads to an ED visit or a hospital readmission,” said Maulik Majmudar, MD, a cardiologist and Biofourmis Clinical Advisory Board member. [APBN]