Cardiosense's CardioTag Wearable Sensor Receives FDA Clearance for Heart Function Monitoring

Cardiosense, a medical AI company, has achieved a significant milestone with FDA clearance for its CardioTag device, a wearable sensor designed to provide noninvasive monitoring of cardiac function. This development marks a pivotal advancement in wearable technology for cardiovascular health management.

Innovative Multimodal Sensor Technology

The CardioTag device stands out as the first multimodal, wearable sensor capable of simultaneously capturing high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals. This comprehensive approach to data collection allows for a more nuanced understanding of cardiac activity.

The FDA clearance specifically authorizes the CardioTag for noninvasive measurement of SCG, ECG, and PPG signals, as well as heart rate and pulse rate. This multi-signal approach provides a robust dataset for analyzing various aspects of cardiac function.

Clinical Applications and Future Developments

Cardiosense's technology is built on over a decade of clinical and scientific research, focusing on developing novel wearable sensors and machine learning algorithms. These algorithms are designed to translate raw physiological signals into clinically actionable parameters, potentially enabling early detection of cardiac disease, personalized therapy guidance, and improved patient outcomes.

Of particular interest is the device's ability to measure seismocardiogram (SCG), a noninvasive technique that detects subtle vibrations on the chest wall associated with cardiac mechanical activity. Clinical studies conducted by Cardiosense have shown that analyzing the SCG waveform alongside ECG and PPG signals can accurately assess cardiac timing intervals, such as left ventricular ejection time (LVET), a measure of cardiac pumping efficiency.

Andrew Carek, co-founder and CTO of Cardiosense, emphasized the significance of this clearance, stating, "The CardioTag clearance marks a pivotal step toward clinical adoption and broader access to pressure-guided treatment. We're excited for the foundational role that the CardioTag device will play in building a noninvasive cardiac AI platform."

Future Integration with AI Algorithms

Cardiosense has ambitious plans for the CardioTag device, aiming to pair it with AI algorithms that utilize the SCG, ECG, or PPG data. One such algorithm, designed to estimate pulmonary capillary wedge pressure (PCWP), has already received FDA Breakthrough Device designation.

A recent prospective, multicenter study published in the Journal of the American College of Cardiology: Heart Failure demonstrated that Cardiosense's algorithm could estimate PCWP values with accuracy comparable to implantable hemodynamic sensors in patients with heart failure and reduced ejection fraction. Once regulatory approval is obtained for the PCWP analysis software, Cardiosense intends to integrate it with the CardioTag device for advanced heart failure management.

This FDA clearance for the CardioTag device represents a significant step forward in noninvasive cardiac monitoring technology, potentially offering new avenues for early detection, personalized treatment, and improved outcomes in cardiovascular care.