Cardiosense wins FDA clearance for wearable sensor
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.
Clearance authorizes the device for the noninvasive measurement of SCG, ECG and PPG signals. It can also measure heart rate (HR) and pulse rate (PR). SCG, a non-invasive technique, measures subtle vibrations on the chest wall associated with cardiac mechanical activity. Clinical studies demonstrated that analyzing SCG alongside ECG and PPG signals can help accurately assess cardiac timing intervals such as left ventricular ejection time (LVET)—a measure of how efficiently the heart is pumping blood—compared to the current standard-of-care.
