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.
Cardiosense plans to begin exploring pilots pairing CardioTag with AI algorithms using SCG, ECG or PPG data from the device.
“Our team is thrilled to achieve this critical milestone as part of our mission to advance cardiac care. Traditionally, noninvasive cardiac monitoring has primarily focused on ECG and rhythm analysis. With the CardioTag device, we are adding an entirely new dimension by also capturing physiological data on cardiac mechanics and blood flow, providing unprecedented visibility into a patient’s cardiac function, hemodynamics, and volume status,” said Amit Gupta, co-founder and CEO of Cardiosense.
