FDA grants approval for Cardiosense's CardioTag Medical Device
FDA Clears Revolutionary Wearable Cardiac Sensor for Advanced Heart Monitoring
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Cardiosense CardioTag device, a groundbreaking, multimodal wearable sensor designed for advanced noninvasive cardiac function monitoring. This Class II medical device, now approved for use, promises to bring precision hemodynamic insights into routine patient care, regardless of setting.
The CardioTag device is the culmination of over a decade of clinical research and cross-disciplinary innovation in biomedical engineering, cardiovascular medicine, and data science. It was developed with the aim of creating a technology that truly caters to patients, offering a comprehensive view of cardiac electrical, mechanical, and hemodynamic function.
The device simultaneously captures high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals, as well as heart rate and pulse rate. These signals provide a rich data input upon which AI models for cardiovascular parameters can be developed, such as the pulmonary capillary wedge pressure (PCWP) algorithm.
Key capabilities of the CardioTag device include measurement of ECG (electrical heart activity), PPG (blood volume and pulse waveform reflecting blood flow and hemodynamics), and SCG (subtle chest wall vibrations linked to cardiac mechanical activity). The device also supports the assessment of cardiac timing intervals such as left ventricular ejection time (LVET), a vital measure of how efficiently the heart pumps blood.
The FDA clearance marks a pivotal step toward clinical adoption and broader access to pressure-guided treatment. Upon regulatory approval for the PCWP Analysis Software, the algorithm will be paired with the CardioTag device for advanced heart failure management.
According to Omer Inan, PhD, Co-founder and Chief Scientific Officer at Cardiosense, the FDA clearance is a significant step toward bringing precision hemodynamic insights into everyday patient care, regardless of setting. He further stated that this milestone is deeply meaningful in the journey of turning a bold idea into a practical, everyday technology.
Clinical studies conducted by Cardiosense have shown that analyzing the SCG waveform alongside ECG and PPG signals can be used to accurately assess cardiac timing intervals. In fact, the Cardiosense AI algorithm for pulmonary capillary wedge pressure (PCWP), which received FDA Breakthrough Device designation, could estimate PCWP values with accuracy on par with implantable hemodynamic sensors in patients with heart failure with reduced ejection fraction (HFrEF).
The CardioTag device is intended for use across care settings, from hospital environments to home monitoring, facilitating noninvasive, comprehensive longitudinal cardiovascular disease management. Cardiosense will begin exploring pilots with the CardioTag device paired with AI algorithms using the SCG, ECG, or PPG data from the device.
In summary, the Cardiosense CardioTag device is an FDA-cleared, AI-enabled wearable sensor platform providing multimodal cardiac signal acquisition for advanced cardiovascular disease management. With demonstrated clinical potential in assessing cardiac function metrics beyond traditional ECG alone, further software enhancements for detailed hemodynamic analysis, such as PCWP estimation, are expected pending additional FDA clearances.
[1] Cardiosense. (2025). Cardiosense announces FDA clearance of CardioTag device for advanced noninvasive cardiac function monitoring. Retrieved from https://www.cardiosense.com/news/cardiosense-announces-fda-clearance-of-cardiotag-device-for-advanced-noninvasive-cardiac-function-monitoring/
[2] U.S. Food and Drug Administration. (2025). FDA grants 510(k) clearance for Cardiosense's CardioTag device for advanced noninvasive cardiac function monitoring. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-grants-510k-clearance-cardiosenses-cardiotag-device-advanced-noninvasive-cardiac-function
[3] Journal of the American College of Cardiology: Heart Failure. (2024). Prospective, multicenter study of the Cardiosense CardioTag device for noninvasive measurement of seismocardiogram, electrocardiogram, and photoplethysmogram signals in heart failure patients. Retrieved from https://www.onlinejacc.org/content/early/2024/06/15/J.JACC.HO.24.006569
[4] American Heart Association. (2024). Late-Breaking Science: Cardiosense's CardioTag device for noninvasive measurement of seismocardiogram, electrocardiogram, and photoplethysmogram signals in heart failure patients. Retrieved from https://scientificsessions.ahajournals.org/content/early/2024/06/15/LBS.35.1_11406
[5] Cardiosense. (2025). Cardiosense's CardioTag device receives FDA Breakthrough Device designation for PCWP estimation in heart failure patients. Retrieved from https://www.cardiosense.com/news/cardiosenses-cardiotag-device-receives-fda-breakthrough-device-designation-for-pcwp-estimation-in-heart-failure-patients/
- The Cardiosense CardioTag device, cleared by the FDA, represents a significant advancement in digital health, bringing precision hemodynamic insights to patient care in various settings.
- With its ability to capture multiple cardiac signals, such as ECG, PPG, and SCG, the CardioTag device leverages artificial intelligence to offer a comprehensive view of cardiac electrical, mechanical, and hemodynamic function, contributing to the field of medical-conditions management.
- The CardioTag device also supports the assessment of cardiac timing intervals like left ventricular ejection time, which is crucial for cardiovascular-health monitoring and management of medical-conditions such as heart failure.
- Future software enhancements for the CardioTag device, pending FDA clearances, aim to further improve hemodynamic analysis, such as the development of AI models for pulmonary capillary wedge pressure estimation, which could potentially revolutionize health-and-wellness management and treatment for various medical-conditions.
