Chicago-based Cardiosense has received 510(k) clearance from the FDA for its CardioTag device, a multimodal wearable sensor.
The CardioTag is designed to provide clinicians with a comprehensive, noninvasive view of cardiac function by simultaneously measuring electrocardiogram, photoplethysmogram and seismocardiogram data. The device also reports heart rate and pulse rate, according to a July 30 Diagnostic and Interventional Cardiology report.
The device will also support future development of AI-powered cardiovascular monitoring tools. Cardiosense plans to pair CardioTag with algorithms to estimate metrics such as pulmonary capillary wedge pressure, pending further regulatory approval, according to the report.
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