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Cardiosense’s CardioTag Wins FDA Clearance for AI-Driven Heart Monitoring
The FDA has cleared Cardiosense’s CardioTag, a wearable device designed for noninvasive heart monitoring. Worn on the chest, the sensor tracks electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals, along with heart and pulse rates, to assess cardiac performance.
Cardiosense aims to integrate this multi-signal data into AI-based cardiovascular models, including one for pulmonary capillary wedge pressure (PCWP)—an early marker of heart failure. The company previously received Breakthrough Device Designation for the PCWP algorithm, though FDA clearance for the model is pending.
Early research shows CardioTag could match implantable sensors like Abbott’s CardioMEMS in accuracy while offering a noninvasive alternative. The device also successfully measured left ventricular ejection time (LVET)—a key indicator in heart failure diagnostics—on par with existing wearables.
Backed by $15.1M in funding, Cardiosense positions CardioTag as the core of its expanding AI cardiac monitoring platform.
01-08-2025
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