OMRON Healthcare Wins FDA De Novo Authorization for AFib-Detecting BP Tech

The U.S. Food and Drug Administration (FDA) has awarded De Novo authorization to OMRON Healthcare for its new home blood pressure monitors that feature artificial intelligence (AI)-powered atrial fibrillation (AFib) detection. The company’s unprecedented machine learning IntelliSense AFib algorithm automatically analyzes the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, a leading cause of stroke.¹

“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,” OMRON Healthcare President/CEO Ranndy Kellogg said. “AFib is a serious condition that is under-discussed, under-checked and underdiagnosed. We want to change that. Our new AFib detection feature keeps closer watch on this high stroke risk condition during routine blood pressure monitoring, making AFib detection more widely accessible and more often practiced so we can help reduce the health risk.”

AFib is the most common type of heart arrythmia.² Left untreated, it increases the risk of stroke, heart failure, myocardial infarction, chronic kidney disease, and dementia.

The FDA granted OMRON Healthcare medical-device authorization for the new AFib detection technology through the agency’s De Novo classification,³ a regulatory pathway for novel innovations for which there is no prior legally marketed device. The De Novo pathway is currently being used by the FDA to review digital health products and medical devices that incorporate AI technologies.⁴

“OMRON invested in the De Novo pathway to affirm our commitment to medical-grade accuracy as we work to develop and introduce first-of-their-kind technologies,” Kellogg stated.

Built into OMRON blood pressure monitors, IntelliSense AFib—which incorporates more than 300 mathematical indices into a machine learning algorithm—analyzes the Pressure Pulse Wave generated as the cuff inflates to accurately detect AFib-specific disturbances.

A clinical study published last fall in Heart Rhythm Journal⁵ found that OMRON blood pressure monitors with Intellisense AFib demonstrated a 95% sensitivity and 98% specificity for AFib detection.

Experts recognize AFib as a rapidly accelerating health epidemic.⁶ 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 Cardiology⁷ 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.⁸ Risk factors for AFib include high blood pressure, obesity, diabetes, smoking, heavy use of alcohol, and sleep apnea.⁹

“High blood pressure affects more than half of all U.S. 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,” Kellogg commented. “Ninety percent of heart attacks and strokes are preventable through regular blood pressure monitoring and behavior change.¹⁰ Teaching those we serve how to monitor and act for better heart health is what Going for Zero is all about.”

OMRON is planning to launch new upper arm blood pressure monitors in the United States with advanced AFib detection early this year.

OMRON Healthcare Inc. manufactures and distributes personal heart health products and develops technologies supporting respiratory and pain management care. Boasting more than 50 years of medical device category leadership, OMRON’s products include a full range of home blood pressure monitors, nebulizers, and TENS devices. The company’s mission is eliminating heart attacks and strokes. With more than 350 million devices sold globally, OMRON claims it provides the world’s most recommended blood pressure monitors by healthcare professionals. The company provides products and services in more than 130 countries.

References
¹ CDC AFib and Stroke https://www.cdc.gov/heart-disease/about/atrial-fibrillation.html?CDC_AAref_Val=https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
² CDC About Atrial Fibrillation https://www.cdc.gov/heart-disease/about/atrial-fibrillation.html?CDC_AAref_Val=https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
³ FDA De Novo https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request
⁴ FDA De Novo AI First https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-device-uses-artificial-intelligence-help-detect-potential-signs-colon
⁵ Heart Rhythm Journal, October 2024 https://www.heartrhythmjournal.com/article/S1547-5271(24)02520-7/fulltext
⁶ AHAIASA Journals https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.120.316340
⁷ JACC study https://medconnection.ucsfhealth.org/news/how-many-people-have-a-fib-three-times-more-than-we-thought
⁸ American Stroke Association https://scnow.com/news/health/many-people-have-atrial-fibrillation-but-may-not-know-it/article_bb910f20-cc44-11e9-8406-c39ac04db63b.html
⁹ NIH https://pmc.ncbi.nlm.nih.gov/articles/PMC8158444/
¹⁰ Cleveland Clinic https://newsroom.clevelandclinic.org/2021/09/29/90-percent-of-heart-disease-is-preventable-through-healthier-diet-regular-exercise-and-not-smoking