Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment
Shots:
- The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function
- Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published in The JACC: Heart Failure & presented atAHA’24
- CardioTag device is a multimodal wearable sensor that captures high-fidelity ECG, PPG, & SCG signals, with the company planning to initiate pilot programs pairing it with AI algorithms to analyze these signals for advanced cardiac monitoring
Ref: Businesswire | Image: Carrdiosense | Press Release
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