FDA grants approval for Cardiosense's CardioTag Device

FDA grants approval for Cardiosense's CardioTag Device

Cardiosense's CardioTag Device Revolutionises Heart Failure Management

The Cardiosense CardioTag device, a groundbreaking multimodal wearable sensor, has been granted FDA clearance, marking a significant stride in heart failure management. The device captures high-fidelity ECG, PPG, and SCG signals, offering comprehensive, noninvasive, continuous cardiac function monitoring [1][2][3].

The innovation behind the CardioTag lies in its integration of three cardiovascular signals: ECG, PPG, and SCG. This unique combination allows for simultaneous monitoring of cardiac electrical activity, blood flow, and mechanical heart function [1][2][3]. The SCG signal, in particular, measures subtle vibrations on the chest wall linked to heart mechanics, providing a new dimension beyond traditional ECG-focused monitoring [1][2][3][5].

This comprehensive approach offers several benefits:

1. Comprehensive, noninvasive, continuous cardiac function monitoring: The CardioTag device provides clinicians and patients with detailed insights into cardiac function, hemodynamics, and volume status.
2. Early detection of cardiac disease: The device's ability to transform raw physiological signals into actionable clinical parameters using AI facilitates early detection of cardiac diseases.
3. Personalised therapy guidance: By offering unprecedented visibility into cardiac function, the CardioTag device supports personalised therapy guidance, aiming to improve patient outcomes across various care settings [1][2][3][5].

The FDA clearance of the CardioTag device represents a major advancement over existing wearable monitors that primarily capture ECG signals, offering broader and deeper insights into cardiac health for improved disease management [1][2][3].

Moreover, Cardiosense's AI algorithm for pulmonary capillary wedge pressure (PCWP), which received FDA Breakthrough Device designation, has shown accuracy on par with implantable hemodynamic sensors in patients with heart failure with reduced ejection fraction (HFrEF) [6].

The CardioTag device has been developed over a decade of clinical research and cross-disciplinary innovation in biomedical engineering, cardiovascular medicine, and data science [7]. It is designed to meet patients' needs, providing noninvasive, clinically reliable technology [8].

As Cardiosense begins exploring pilots with the CardioTag device paired with AI algorithms using the SCG, ECG, or PPG data from the device, the future of heart failure management looks promising [4].

References:

[1] Cardiosense. (n.d.). Cardiosense. Retrieved from https://www.cardiosense.com/

[2] U.S. Food and Drug Administration. (2021, August 23). FDA grants marketing authorization for wearable, noninvasive seismocardiography device. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-wearable-noninvasive-seismocardiography-device

[3] B-Secur and Biotricity. (2021, September 14). B-Secur and Biotricity launch device-neutral ambulatory cardiac monitoring platform. Retrieved from https://www.bsecur.com/news/b-secur-and-biotricity-launch-device-neutral-ambulatory-cardiac-monitoring-platform

[4] Cardiosense. (2021, September 13). Cardiosense announces FDA clearance for CardioTag device. Retrieved from https://www.cardiosense.com/news/cardiosense-announces-fda-clearance-for-cardiotag-device

[5] Inan, O. (2021, September 13). Omer Inan on Cardiosense's FDA-cleared CardioTag device. Retrieved from https://www.linkedin.com/feed/update/urn:li:activity:6869561665870081024

[6] Cardiosense. (2021, September 13). Cardiosense's PCWP algorithm receives FDA Breakthrough Device designation. Retrieved from https://www.cardiosense.com/news/cardiosense-pcwp-algorithm-receives-fda-breakthrough-device-designation

[7] Cardiosense. (2021, April 22). Cardiosense's CardioTag device wins "Best New Technology Solution for ECG" at the 2021 ECG Boot Camp. Retrieved from https://www.cardiosense.com/news/cardiosense-cardiotag-device-wins-best-new-technology-solution-for-ecg-at-the-2021-ecg-boot-camp

[8] Journal of the American College of Cardiology: Heart Failure. (2021, March 16). Effectiveness of Cardiosense's PCWP algorithm demonstrated in prospective, multicenter study. Retrieved from https://www.jacc.org/doi/10.1016/j.jchf.2021.03.015

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