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Cardiosense Obtains FDA Clearance For Wearable Cardiac Sensor

August 12, 2025

By Mark Rubinshtein

(August 5, 2025)  Cardiovascular disease is a leading cause of death, with over 900,00 deaths reported in the United States in 2023.  In this context many companies have pursued products to help diagnose or sense heart activity.  In the last few years, products that use AI for this purpose have been under development.

One example is the CardioTag.  Cardiosense, the Chicago-based medical AI company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CardioTag wearable heart monitor.  The device can capture various cardiac data that would allow doctors to monitor a patient’s heart function.  CardioTag is a multimodal wearable sensor designed to noninvasively measure seismocardiogram, photoplethysmogram, electrocardiogram signals along with heart and pulse rate, enabling comprehensive cardiac assessments from hospital to home.  The data captured by the device can then be analyzed combined with AI algorithms to improve outcomes for cardiac patients.  Cardiosense will begin exploring pilot programs pairing the CardioTag device with AI algorithms to enable early detection of cardiac dysfunction.

Despite the seeming use of AI, Amit Gupta, Co-founder and CEO of Cardiosense did not emphasize AI in his comments: “Traditionally, noninvasive cardiac monitoring has primarily focused on ECG and rhythm analysis. With the CardioTag device, we are adding an entirely new dimension by also capturing physiological data on cardiac mechanics and blood flow, providing unprecedented visibility into a patient’s cardiac function, hemodynamics, and volume status.”

However, a recent patent publication owned by the company does include AI aspects.  Cardiosense is the Assignee of a recently filed International patent application related to analysis of cardiac data.  The application published as International Patent Publication No. WO 2025/137624 on June 26, 2025.  Its claims refer to transforming a sensor signal “into a format associated with a language model.”  Interested observers may watch to see if any of such AI aspects are addressed in further patent prosecution.

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