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# Home AFib Blood Pressure Monitor De Novo Granted
- URL: https://www.fdaweb.com/home-afib-blood-pressure-monitor-de-novo-granted/
- Published: 2024-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:47:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158187

FDA has granted a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring artificial intelligence (AI)-powered atrial fibrillation detection. The company says its novel machine learning IntelliSense AFib algorithm automatically analyzes the pressure pulse wave generated during blood pressure measurement to detect AFib, which is a leading cause of stroke. “AFib is the most common type of heart arrhythmia,” it says, adding that if not treated it can increases the risk of stroke, heart failure, myocardial infarction, chronic kidney disease, and dementia.

The device’s IntelliSense AFib incorporates over 300 mathematical indices into the machine learning algorithm, according to the company. A clinical study published in the October issue of *Heart Rhythm Journal* found that the blood pressure monitors demonstrated a sensitivity of 95% and a specificity of 98% for AFib detection, it says.