Revolutionary device integrates advanced AI to enable routine screening for atrial fibrillation.
Omron Healthcare has received FDA de novo authorization for its IntelliSense AFib-equipped blood pressure monitors, marking a milestone in AI-driven health technology. The device detects atrial fibrillation (AFib) with 95% sensitivity and 98% specificity, supporting early intervention for a condition linked to stroke and other severe health risks.
Making AFib Screening Accessible
Omron’s IntelliSense AFib monitors use machine learning to analyze the Pressure Pulse Wave during blood pressure measurements, seamlessly incorporating AFib detection into a common health routine.
“AFib is under-discussed, under-checked, and underdiagnosed,” said Ranndy Kellogg, CEO of Omron Healthcare. “With IntelliSense AFib, we aim to make screening easy and routine, reducing the risk of heart attack and stroke.”
Breakthrough Technology and Validation
The IntelliSense AFib algorithm leverages 300+ mathematical indices to achieve its high accuracy. A clinical study published in Heart Rhythm Journal validated the device’s 95% sensitivity and 98% specificity, earning FDA de novo authorization as a novel, medically accurate innovation.
Addressing a Public Health Crisis
AFib affects millions, with 40% of cases going undiagnosed. Its risk factors, including high blood pressure, obesity, and diabetes, underscore the need for routine screening. Omron’s device aligns with its “Going for Zero” mission to eliminate heart attacks and strokes.
“With this de novo authorization, we make AFib detection accessible for millions through everyday blood pressure monitoring,” added Kellogg.
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