The machine learning IntelliSense AFib algorithm automatically analyses the Pressure Pulse Wave generated during blood pressure measurement to detect AFib. Credit: OMRON Healthcare / PRNewswire.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.