OMRON Healthcare has secured De Novo authorisation from the US Food and Drug Administration (FDA) for new home blood pressure monitors with AI-powered atrial fibrillation (AFib) detection feature.
AFib is the most prevalent heart arrhythmia, increasing the risk of stroke, heart failure, and other health issues if left untreated.
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Integrated into OMRON’s monitors, the IntelliSense AFib algorithm analyses the Pressure Pulse Wave during measurement to detect AFib with high precision.
The De Novo authorisation was announced as the company prepares to attend the American Heart Association Scientific Sessions in Chicago.
The FDA’s De Novo classification is a regulatory pathway for innovations, particularly those incorporating AI technologies.
OMRON Healthcare president and CEO Ranndy Kellogg said: “OMRON Healthcare is making AFib screening a more integral part of our blood pressure monitoring experience as part of our Going for Zero mission to eliminate heart attack and stroke.
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By GlobalData“Our new AFib detection feature keeps a closer watch on this high stroke risk condition during routine blood pressure monitoring, making AFib detection more widely accessible and more often practised so we can help reduce the health risk.”
OMRON’s IntelliSense AFib uses more than 300 mathematical indices within a machine learning algorithm.
This technology demonstrated 95% sensitivity and 98% specificity for AFib detection in a clinical study published in the Heart Rhythm Journal last month.
Initial findings were presented at the Heart Rhythm Society Annual Meeting in May 2024.
A study published in the Journal of the American College of Cardiology in September 2024 revealed that AFib is three times more common than previously thought.
In the US, OMRON plans to launch new upper-arm blood pressure monitors with the latest AFib detection early next year.
