Advancing its Going for Zero mission, OMRON innovation makes AFib screening an integral part of the brand's routine home blood pressure monitoring experience HOFFMAN ESTATES, Ill. , Nov. 14, 2024 /PRNewswire/ -- In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.
S. Food and Drug Administration (FDA) has granted the company its De Novo authorization to market new home blood pressure monitors featuring breakthrough AI-powered atrial fibrillation detection. In a medical device first, OMRON's novel machine learning IntelliSenseTM AFib algorithm automatically analyzes the Pressure Pulse Wave generated during blood pressure measurement to detect AFib, a leading cause of stroke 1 .
OMRON executives announced the De Novo authorization as the company prepares to participate in the American Heart Association Scientific Sessions in Chicago . "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," said OMRON Healthcare President and CEO Ranndy Kellogg . "AFib is a serious condition that is under-discussed, under-checked and underdiagnosed.
We want to change that." "Our new AFib detection feature keeps closer watch on this high stroke risk condition during routine blood pressure monitoring, making AFib detection more widely accessible and more often practiced so we can help reduce the health risk," said Kellogg. AFib.
