SINGAPORE healthtech startup Biofourmis, headquartered in Boston, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its patient data-monitoring solution, it announced on Thursday night.
The artificial intelligence-powered Biovitals Analytics Engine has been approved as a medical device for constant monitoring of individual patients' physiology-based health data. The engine is the foundation of Biofourmis' set of Biovitals products.
"Receiving this important regulatory approval will only accelerate the development and commercialisation of these innovative digital therapeutic solutions," said Biofourmis chief executive officer and founder Kuldeep Singh Rajput.
The 510(k) market clearance was obtained upon the FDA's determination that the application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
Biofourmis' application was based on clinical studies monitoring patients with complex chronic conditions such as heart failure, chronic obstructive pulmonary disease and atrial fibrillation at home, in a real-world setting.
This is the second FDA approval received by Biofourmis. The first, in May, was for its Biovitals RhythmAnalytics platform, a cloud-based software that automatically interprets types of cardiac arrhythmia.