FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare announced the U.S. Food and Drug Administration (FDA) has granted the company its De Novo authorization to market new home blood pressure monitors featuring breakthrough AI-powered atrial fibrillation detection. In a medical device first, OMRON's novel machine learning IntelliSense™ AFib algorithm automatically analyzes the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, a leading cause of stroke1.