The US Food and Drug Administration has authorised OMRON Healthcare to market home blood pressure monitors using AI-based atrial fibrillation detection. OMRON’s machine learning IntelliSense AFib algorithm analyses the Pressure Pulse Wave generated during blood pressure measurement to detect atrial fibrillation, a leading cause of stroke.

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

The FDA granted OMRON Healthcare medical-device authorisation for the new AFib detection technology via the agency’s De Novo classification. This is 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.

Built into OMRON blood pressure monitors, IntelliSense AFib – which incorporates over 300 mathematical indices into a machine learning algorithm – analyses 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 Journal 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 presented at the Heart Rhythm Society Annual Meeting in May 2024.

“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 practised so we can help reduce the health risk,” said Kellogg.