Summary: Omron Healthcare has received FDA de novo authorization for its AI-powered IntelliSense AFib-equipped blood pressure monitors. The technology detects atrial fibrillation with 95% sensitivity and 98% specificity, supporting early detection of a condition linked to severe health risks.

Key Takeaways:

  • Omron’s IntelliSense AFib algorithm integrates advanced AI to improve detection of AFib during routine blood pressure monitoring.
  • With De Novo authorization, Omron aims to make AFib screening routine, addressing a significant public health challenge.

Omron Healthcare announces that the U.S. FDA has granted de novo authorization for its new home blood pressure monitors featuring AI-powered atrial fibrillation (AFib) detection. The IntelliSense AFib algorithm uses machine learning to analyze the Pressure Pulse Wave during blood pressure measurement, detecting AFib, a leading cause of stroke.

Making AFib Screening Routine

“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,” says Ranndy Kellogg, Omron Healthcare president and CEO. “AFib is a serious condition that is under-discussed, under-checked, and underdiagnosed. We want to change that.”

AFib is the most common heart arrhythmia and significantly increases the risk of stroke, heart failure, and other health issues. Approximately 40% of AFib cases are asymptomatic, underscoring the importance of regular screening.

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Breakthrough Technology and Clinical Validation

The IntelliSense AFib algorithm incorporates over 300 mathematical indices to analyze the Pressure Pulse Wave, detecting disturbances specific to AFib with high accuracy. A clinical study published in the October Heart Rhythm Journal demonstrated the algorithm’s sensitivity of 95% and specificity of 98%.

The FDA granted the de novo authorization as a pathway for novel innovations, affirming the device’s medical-grade accuracy.

Addressing a Growing Health Epidemic

Experts consider AFib a rapidly growing health crisis, with recent studies indicating its prevalence is three times higher than previously estimated. The American Stroke Association reports that millions of Americans with AFib remain undiagnosed, with risk factors including high blood pressure, obesity, diabetes, smoking, and sleep apnea.

“High blood pressure affects more than half of all U.S. adults and is a top AFib risk factor,” says Kellogg. “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.”