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Machine learning

Cardiosense Receives FDA Clearance for Revolutionary Wearable Cardiac Sensor

Strategic Insights

— 1 min read

Cardiosense has achieved a significant milestone with the FDA clearance of its CardioTag device, a noninvasive wearable sensor designed to monitor cardiac function. This innovative technology captures high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals, providing a comprehensive understanding of cardiac activity. The device has been cleared for the noninvasive measurement of SCG, ECG, and PPG signals, as well as heart rate and pulse rate. This achievement is the result of over a decade of clinical and scientific research, and it has the potential to detect early signs of cardiac disease, guide personalized therapy, and improve patient outcomes.

Key Takeaways:

  • The CardioTag device is the first multimodal, wearable sensor to simultaneously capture ECG, PPG, and SCG signals, offering a comprehensive understanding of cardiac activity.
  • The device has been cleared for noninvasive measurement of SCG, ECG, and PPG signals, as well as heart rate and pulse rate.
  • Cardiosense's AI algorithm for pulmonary capillary wedge pressure (PCWP) has received FDA Breakthrough Device designation and is set to be paired with the CardioTag device for advanced heart failure management.
  • Clinical studies conducted by Cardiosense have demonstrated the accuracy of analyzing SCG waveforms alongside ECG and PPG signals in assessing cardiac timing intervals.
  • The CardioTag device was built on over a decade of clinical and scientific research, developing novel wearable sensors and machine learning algorithms.
  • Cardiosense plans to launch pilots with the CardioTag device paired with AI algorithms using SCG, ECG, or PPG data from the device.

Statistics:

  • 10+ years: duration of clinical and scientific research that led to the development of the CardioTag device.
  • 100%: increase in the accuracy of left ventricular ejection time (LVET) measurements using SCG, ECG, and PPG signals compared to the current standard-of-care.
  • 1 device: the CardioTag device, which has been cleared by the FDA for noninvasive measurement of SCG, ECG, and PPG signals.
  • 2024: the year in which the American Heart Association's Scientific Sessions took place, where the Cardiosense's algorithm was presented as Late-Breaking Science.

Sources:

  • Cardiosense press release announcing FDA clearance for the CardioTag device
  • Journal of the American College of Cardiology: Heart Failure, "Accurate Estimation of Pulmonary Capillary Wedge Pressure Using a Novel Cardiac Algorithm and Wearable Sensors"
  • American Heart Association's 2024 Scientific Sessions program

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