FDA Approves Artificial Intelligence-Based Physiological Monitor

The US Food and Drug Administration (FDA) has given the green light for the Biovitals Analytics Engine, a new machine learning and artificial intelligence (AI) device for ambulatory physiological monitoring.

The device, developed by Biofourmis, received 510(k) clearance as part of a recent push for machine learning and AI in the Software as a Medical Device category.

The engine can process multiple physiology signals and is considered the foundation for the company’s digital therapeutics product pipeline.

The product receives physiologic data, including heart rate, respiratory rate, and activity in near real-time from FDA-cleared sensors and then leverages AI and machine learning technology to identify the correlation between multiple vital signs and the patient’s daily activities.

The 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 could be up to a few weeks before an event would have occurred without intervention, providing enough time for clinicians to take measures to change the trajectory of the disease.

“The Biovitals Analytics Engine helps to fill a critical unmet medical need in heart failure care," Raj Khandwalla, MD, 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, said in a statement. “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.”

Stakeholders said the new device could reduce hospital readmissions, while decreasing the need for emergency department visits and providing a foundation for pharmaceutical researchers and medical device manufacturers to develop more effective solutions.

The approval marks the second time Biofourmis garnered market authorization, after the Biovitals RhythmAnalytics platform, a cloud-based software system for the automated interpretation of more than 15 types of cardiac arrhythmias was approved in May.

“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,” Kuldeep Singh Rajput, CEO and founder of Biofourmis, said in a statement. “Receiving this important regulatory approval will only accelerate the development and commercialization of these innovative digital therapeutic solutions.”