Cardiosense announced today that it received FDA 510(k) clearance for its CardioTag wearable sensor device.
The company touts CardioTag as the first multimodal, wearable sensor that simultaneously captures high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals. It aims to enable clinicians and patients with a comprehensive noninvasive solution to assess cardiac function across care settings.
The company’s novel, wearable sensor and AI help translate raw physiological signals into clinically actionable parameters. It helps to detect early signs of cardiac disease, guide personalized therapy and improve patient outcomes.