The FDA has approved a new wearable device from Omron Healthcare that can detect atrial fibrillation (AFib) without relying on electrical signals from the heart. This device, which resembles a standard blood pressure cuff, incorporates artificial intelligence to analyze pulse waves as the cuff inflates.
Omron’s innovative technology aims to integrate AFib screening into regular blood pressure monitoring. This initiative addresses critical health issues, including heart attacks and strokes.
“AFib is a serious condition that is often overlooked and underdiagnosed,” said Ranndy Kellogg, President and CEO of Omron.
“Our new feature allows for closer monitoring of this high-risk condition during routine blood pressure checks, making AFib detection more accessible and frequent, ultimately helping to reduce health risks.”
Clinical trials of Omron’s IntelliSense AFib machine learning program demonstrated impressive results, achieving a sensitivity of 95% and a specificity of 98% when compared to a 12-lead electrocardiogram.
These findings were published last month in the Heart Rhythm Journal after being presented at the Heart Rhythm Society’s annual meeting earlier this year.
The AI algorithm evaluates changes in the intervals between heartbeats and analyzes over 300 mathematical parameters to interpret pressure waves accurately.
If left untreated, AFib can significantly increase the risk of stroke, heart failure, chronic kidney disease, and dementia.
Omron estimates that about 40% of AFib cases go undiagnosed.
“High blood pressure affects more than half of U.S. adults and is a major risk factor for AFib,” Kellogg noted. “Regular blood pressure monitoring and lifestyle changes can prevent up to 90% of heart attacks and strokes.”
Omron plans to launch new upper arm blood pressure monitors equipped with this AI technology in early 2025.
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