Cardiosense Receives FDA 510(k) Clearance for the CardioTag™ Device, Paving the Way for Advanced Cardiac Function Monitoring

Cardiosense wins FDA clearance for wearable heart monitor

The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.

Cardiosense wins FDA Clearance for wearable heart monitor, CardioTag

Cardiosense's CardioTag gains FDA clearance, advancing cardiac monitoring with wearable technology for personalized, noninvasive heart health insights.

Cardiosense Receives FDA 510(k) Clearance for the CardioTag™ Device, Paving the Way for Advanced Cardiac Function Monitoring

CHICAGO--(BUSINESS WIRE)--Jul 30, 2025-

FDA grants 510(k) clearance for Cardiosense’s wearable sensor

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardioTag, Cardiosense’s multimodal, wearable sensor.The post FDA grants 510(k) clearance for Cardiosense’s wearable sensor appeared first on Medical Device Network.

Cardiosense's CardioTag Device Gets FDA 510(k) Clearance for Advanced Cardiac Function Monitoring

The CardioTag device fuses multiple sensing modalities to capture insights about the relationship between cardiac mechanics, electrical impulses and blood flow — and can be used by AI algorithms to assess cardiac pressures and volume status