The blood pressure monitor demonstrated high accuracy for AFib detection in a clinical study.
Summary: The FDA has granted De Novo authorization for OMRON Healthcare’s new home blood pressure monitor equipped with AI-powered atrial fibrillation (AFib) detection. These devices use the IntelliSense AFib algorithm, incorporating over 300 mathematical indices to analyze pressure pulse waves during measurements and detect AFib with high accuracy (95% sensitivity, 98% specificity). With millions of Americans undiagnosed and AFib increasingly prevalent, this innovation aims to make screening more accessible and routine. The monitors will be available in the US in early 2025 as part of OMRON’s mission to reduce heart attack and stroke risks.
Key Takeaways:
- AI-Powered AFib Detection Approved: The FDA authorized OMRON’s blood pressure monitors with AI-based AFib detection.
- High Accuracy in AFib Screening: A clinical study demonstrated 95% sensitivity and 98% specificity for detecting AFib.
- Focus on Preventative Heart Health: The innovation aligns with efforts to integrate AFib screening into routine blood pressure monitoring, aiming to prevent heart attacks and strokes through early detection and intervention.
OMRON Healthcare today announced the US Food and Drug Administration (FDA) has granted the company its De Novo authorization to market new home blood pressure monitors featuring artificial intelligence (AI)-powered atrial fibrillation (AFib) detection.
OMRON’s novel machine learning IntelliSense AFib algorithm automatically analyzes the pressure pulse wave generated during blood pressure measurement to detect AFib. 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 as part of our Going for Zero mission to eliminate heart attack and stroke,” says OMRON Healthcare president and CEO Ranndy Kellogg, in a release. “AFib is a serious condition that is under-discussed, under-checked and underdiagnosed. We want to change that.”
De Novo Pathway for AI Innovations
The FDA granted OMRON Healthcare medical-device authorization for the new AFib detection technology via the agency’s De Novo classification, a regulatory pathway for novel innovations for which there is no prior legally marketed device. The De Novo pathway is now being used by the FDA to review digital health products and medical devices that incorporate AI technologies.
A clinical study published in the October 2024 Heart Rhythm Journal found that OMRON blood pressure monitors with Intellisense AFib demonstrated a sensitivity of 95% and a specificity of 98% for AFib detection. Clinical findings were initially presented at the Heart Rhythm Society Annual Meeting in May 2024.
Addressing the Growing AFib Epidemic
Experts recognize AFib as a rapidly accelerating health epidemic. While some AFib patients report experiencing heart palpitations, lightheadedness, and extreme fatigue, approximately 40% are asymptomatic, making it difficult to detect and diagnose the condition without regular screening.
The Journal of the American College of Cardiology published a study in September 2024 that found AFib is three times more prevalent than previously estimated. According to the American Stroke Association, millions of Americans with AFib are undiagnosed. Risk factors for AFib include high blood pressure, obesity, diabetes, smoking, heavy use of alcohol, and sleep apnea.
“High blood pressure affects more than half of all US adults and is a top AFib risk factor. With this De Novo authorization, we are making it easy and routine for anyone with an Intellisense AFib-equipped OMRON blood pressure monitor to check for AFib,” says Kellogg in a release. “Ninety percent of heart attacks and strokes are preventable through regular blood pressure monitoring and behavior change. Teaching those we serve how to monitor and act for better heart health is what Going for Zero is all about.”
OMRON will launch new upper arm blood pressure monitors with advanced AFib detection in the US in early 2025.
Photo caption: New home blood pressure monitor with AFib detection
Photo credit: OMRON
