The FDA has granted a de novo clearance to a wearable device—with a form factor you’re familiar with—that can check patients for atrial fibrillation without relying on the electrical signals of the irregular heart rhythm.
Omron Healthcare received the agency green light for artificial-intelligence-powered software that pairs with its at-home blood pressure cuffs, analyzing the waves driven by each pulse of the heart as the cuff inflates.
The company said this will make afib screening an integral part of day-to-day monitoring for hypertension as it works to address some of the main drivers of not only heart attacks but stroke as well.
“Afib is a serious condition that is under-discussed, under-checked and underdiagnosed. We want to change that,” Omron President and CEO Ranndy Kellogg said in a statement. “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.”
According to a clinical trial of Omron’s IntelliSense AFib machine learning program, the approach showed a sensitivity of 95% and a specificity of 98% in afib detection compared to a simultaneous recording with a 12-lead electrocardiogram. The results were published last month in the Heart Rhythm Journal after being presented at the Heart Rhythm Society annual meeting earlier this year.
The AI algorithm accounts for changes in the intervals between pulses as well as more than 300 additional mathematical parameters to help parse the pressure waves.
If left untreated, afib can increase a person’s risk of stroke and heart failure as well as chronic kidney disease and dementia, according to Omron, which estimates that about 40% of cases remain undiagnosed.
“High blood pressure affects more than half of all U.S. adults and is a top afib risk factor,” Kellogg added. “Ninety percent of heart attacks and strokes are preventable through regular blood pressure monitoring and behavior change.”
The company said it plans to launch new upper arm blood pressure monitors equipped with the AI program in early 2025.