OMRON Healthcare has launched a groundbreaking evolution in home cardiovascular care with the introduction of its blood pressure monitors equipped with IntelliSense™ AFib, a machine learning-based algorithm designed to detect atrial fibrillation (AFib). This marks the first time AI-powered AFib screening has been integrated directly into routine blood pressure monitoring. Utilizing over 300 mathematical indices, the system analyzes pulse wave patterns during cuff inflation to identify disturbances characteristic of AFib. The technology received FDA clearance through the De Novo classification pathway, affirming its novelty and clinical value as a first-of-its-kind medical device.
These new OMRON monitors—including the Platinum, 10 Series®, 7 Series®, and Gold models—automatically screen for AFib during every blood pressure reading, requiring no additional user steps. Paired with the OMRON Connect app, users can view and manage readings, receive personalized insights, and share results directly with healthcare providers. This seamless integration allows users to remain proactive about their heart health at home, particularly those with increased AFib risk due to hypertension, obesity, or age. The devices are designed for simplicity and reliability, making clinical-grade monitoring accessible to everyday users.
Atrial fibrillation is a widespread yet often undiagnosed heart condition that significantly increases the risk of stroke, heart failure, and dementia. OMRON’s IntelliSense™ AFib offers a critical tool in bridging the gap between symptomless disease and timely diagnosis. By embedding AFib detection into a routine health activity—measuring blood pressure—OMRON is empowering early intervention and enhancing patient outcomes. This innovation not only supports the company’s "Going for Zero" mission to eliminate preventable heart events but also sets a new benchmark for at-home cardiovascular care worldwide.
MedTech Spectrum's Summary
First-of-its-kind AI Integration: OMRON’s blood pressure monitors now include IntelliSense™ AFib, an FDA-authorized machine learning algorithm that automatically detects atrial fibrillation (AFib) during every blood pressure reading.
Early Detection at Home: The technology enables early identification of AFib—a major risk factor for stroke, heart failure, and dementia—making clinical-grade heart monitoring more accessible and proactive for users at home.
Transforming Preventive Heart Care: By seamlessly integrating AFib screening into a common health routine, OMRON is setting a new standard for preventive cardiovascular care and supporting its mission to eliminate preventable heart attacks and strokes.
