IntelliSense™ AFib algorithm uses machine learning to analyse the Pressure Pulse Wave generated during routine blood pressure measurements.
This breakthrough incorporates over 300 mathematical indices into the algorithm, enhancing its ability to identify AFib accurately and efficiently.
This regulatory approval aligns with OMRON’s ongoing efforts to make AFib detection a routine part of health monitoring. AFib, the most common form of heart arrhythmia, is associated with a heightened risk of stroke, heart failure, and other serious health issues.
Many individuals with AFib are asymptomatic, complicating timely diagnosis and increasing the potential for severe outcomes.
The FDA’s De Novo classification is reserved for novel medical devices that lack a legally marketed predecessor.
Initial findings were presented earlier this year at the Heart Rhythm Society Annual Meeting. These results underscore the potential of this technology to improve early detection and intervention for AFib.
OMRON’s new blood pressure monitors aim to make AFib screening more accessible and convenient, contributing to preventive healthcare efforts.
By incorporating AFib detection into routine blood pressure monitoring, the company seeks to encourage early action to reduce health risks associated with stroke and heart disease.
This advancement supports OMRON’s broader mission to eliminate heart attacks and strokes through innovative technologies and regular health monitoring practices.
Source: https://omronhealthcare.com/press-releases/fda-grants-de-novo-authorization-to-omron-healthcare-for-new-blood-pressure-monitors-with-ai-powered-afib-detection-feature
