Singapore-based health IT start-up Biofourmis has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of Biovitals Analytics Engine for ambulatory physiological monitoring.
The FDA approval for the Biovitals Analytics Engine, powered by machine learning and artificial intelligence (AI), is the second market authorisation secured by Biofourmis.
In May, the company won FDA approval for its Cloud-based Biovitals RhythmAnalytics platform that automates the interpretation of over 15 types of cardiac arrhythmias.
The Analytics Engine is capable of processing multiple physiology signals, as the technology forms the basis of the company’s digital therapeutics product pipeline.
According to Biofourmis, the Biovitals Analytics Engine receives data, including heart rate, respiratory rate and activity, in near real-time from sensors cleared by the FDA.
The device uses AI and machine learning to correlate between multiple vital signs and the patient’s daily activities and builds a biometric signature, which is updated based on incoming data.
A time-series Biovitals Index alerts providers in case of changes in patients’ measured vital signs from their baseline much before an event, providing time for the clinician to take steps to change the trajectory of the disease.
The company claims that the Biovitals platform can reduce hospital readmissions and decrease the need for emergency department (ED) visits.
Biofourmis applied for FDA clearance based on clinical studies involving monitoring patients with chronic conditions such as heart failure, COPD and atrial fibrillation, at home, in a real-world setting.
Research initiatives involving patients with heart failure are also using the Analytics Engine.
Biofourmis has entered into partnerships with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) and Brigham and Women’s Hospital to use BiovitalsHF and Biovitals Analytics Engine and Biovitals RhythmAnalytics to monitor functional capacity and quality of life of patients with heart failure and cardiac arrhythmias.
Biofourmis CEO and founder Kuldeep Singh Rajput said: “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.”