Biofourmis' Biovitals Analytics Engine Receives FDA's 510(k) Clearance for Ambulatory Physiologic Monitoring
Shots:
- The US FDA has approved machine learning and AI-based Biofourmis’ Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring
- The approval follows the approval of its Rhythm Analytics platform- cloud-based software for automated interpretation of 15+ types of cardiac arrhythmias in May’2019. The approval establishes the AI-powered solution as the foundation for Biofourmis’ digital therapeutics product pipeline
- The Biovitals Analytics Engine within the context of the Biovitals HF platform helps to find the critical unmet medical needs in heart failure care
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