OMRON receives OK from FDA
By HME News Staff
Updated 1:54 PM CST, Thu November 14, 2024
HOFFMAN ESTATES, Ill. – OMRON Healthcare has received de novo authorization from the U.S. Food and Drug Administration (FDA) to market new home blood pressure monitors featuring AI-powered atrial fibrillation detection. OMRON's novel machine learning IntelliSense AFib algorithm automatically analyzes the pressure pulse wave generated during blood pressure measurement to detect AFib, a leading cause of stroke. "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." AFib is the most common type of heart arrythmia. Left untreated, it increases risk of stroke, heart failure, myocardial infarction, chronic kidney disease and dementia.
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