In October 2024, Omron Healthcare received de novo authorisation from the US Food and Drugs Administration (FDA) to market its new home blood pressure monitors equipped with AI-powered atrial fibrillation (AFib) detection technology.
The innovation represents a groundbreaking development in digital health, addressing the growing AFib epidemic by integrating advanced AI into routine blood pressure monitoring. The FDA approval highlights Omron’s commitment to delivering medical-grade accuracy through its IntelliSense AFib algorithm, which analyses the pressure pulse wave during blood pressure measurements to detect AFib with remarkable precision.
According to Omron, AFib is the most common heart arrhythmia, and significantly increases the risk of stroke, heart failure and other severe health conditions when left untreated. The FDA’s de novo classification pathway underscores the novelty of this technology, making it the first of its kind to incorporate machine learning into home blood pressure monitors for AFib detection.
Industry experts view this as a pivotal step forward in combatting a condition affecting millions of undiagnosed Americans. A study published in the October 2024 Heart Rhythm Journal reported that Omron’s IntelliSense AFib technology demonstrated a sensitivity of 95% and a specificity of 98% for AFib detection, further validating the effectiveness of this innovation.
AFib affects thousands of undiagnosed Americans
Omron plans to launch its new blood pressure monitors with IntelliSense AFib in the US market in early 2025. The launch aligns with the company’s focus on empowering patients to manage their health proactively, using AI-driven technologies to bridge the gap between traditional and digital healthcare.
As digital health continues to evolve, companies such as Apple, Fitbit and Garmin have introduced consumer-grade wearables with features such as electrocardiogram and heart rate monitoring. However, Omron stands apart with its medical-grade accuracy and healthcare-specific focus, addressing the unique demands of clinical-grade monitoring for chronic disease prevention.
