FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature

OMRON Healthcare, Inc., Press Release

HOFFMAN ESTATES, Ill., Nov. 14, 2024 / -- 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 stroke.¹

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," said OMRON Healthcare President and CEO Ranndy Kellogg. "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," said Kellogg.

AFib is the most common type of heart arrhythmia.² Left untreated, it increases 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 via the agency's De Novo classification³, 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.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," said Kellogg.

Built into OMRON blood pressure monitors, IntelliSense™ AFib – which incorporates over 300 mathematical indices into a machine learning algorithm – analyzes the Pressure Pulse Wave generated as the cuff inflates to detect disturbances specific to AFib with remarkable accuracy.

A clinical study published in the October 2024 Heart Rhythm Journal⁵ found that OMRON blood pressure monitors with Intellisense™ AFib demonstrated a sensitivity of 95 percent and a specificity of 98 percent for AFib detection. Clinical findings were initially presented at the Heart Rhythm Society Annual Meeting in May 2024.

Experts recognize AFib as a rapidly accelerating health epidemic.⁶ While some AFib patients report experiencing heart palpitations, lightheadedness and extreme fatigue, approximately 40 percent 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," said Kellogg. "Ninety percent of heart attacks and strokes are preventable through regular blood pressure monitoring and behavior change10. Teaching those we serve how to monitor and act for better heart health is what Going for Zero is all about."

America's number one doctor and pharmacist recommended blood pressure monitor brand, OMRON will launch new upper arm blood pressure monitors with advanced AFib detection in the U.S. in early 2025.

About OMRON Healthcare, Inc.
OMRON Healthcare, Inc., is the world's leading manufacturer and distributor of personal heart health products and an innovator in technologies supporting respiratory and pain management care. With over 50 years of medical device category leadership, OMRON is passionate about empowering people to take charge of their health at home through precise technology. Its market-leading products include a full range of home blood pressure monitors, nebulizers and TENS devices. The company's mission is Going for Zero, the elimination of heart attacks and strokes. With more than 350 million devices sold globally, OMRON provides the world's most recommended blood pressure monitors by healthcare professionals. OMRON Healthcare strives to improve lives and contribute to a better society by developing innovations that help people prevent, treat, and manage their medical conditions. The company provides products and services in over 130 countries. For more information, visit OmronHealthcare.com.

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