FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature | PR Newswire [Video]

Advancing its Going for Zero mission, OMRON innovation makes AFib screening an integral part of the brand’s routine home blood pressure monitoring experience

, /PRNewswire/ — In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today 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.

OMRON IntelliSense AFib incorporates over 300 mathematical indices into a machine learning algorithm.

OMRON executives announced the De Novo authorization as the company prepares to participate in the American Heart Association Scientific Sessions in Chicago.

“OMRON Healthcare is making AFib screening a more integral part of our blood pressure monitoring experience …