FDA grants clearance for Cardiosense's CardioTag Medical Device
The Cardiosense CardioTag device, a groundbreaking innovation in wearable, noninvasive cardiac monitoring technology, has received FDA clearance. This multimodal, wearable sensor captures Electrocardiogram (ECG), Photoplethysmogram (PPG), and Seismocardiogram (SCG) signals simultaneously, providing a comprehensive understanding of cardiac function, hemodynamics, and volume status[1][3][5].
A New Dimension in Cardiac Monitoring
Traditional cardiac monitoring methods primarily focus on ECG and rhythm analysis. The Cardiosense CardioTag device, however, adds a new dimension by incorporating SCG, which measures subtle vibrations on the chest wall associated with cardiac mechanical activity. This allows for a more accurate assessment of clinically important indicators such as left ventricular ejection time (LVET), a measure of the heart's pumping efficiency[3][5].
Transforming Everyday Patient Care
The CardioTag device is designed to bring precision hemodynamic insights into everyday patient care, regardless of the setting. By providing comprehensive cardiac function and hemodynamic data, the device supports early detection of cardiac dysfunction and guides personalized therapy. It can be used across care settings—from hospitals to home monitoring—enhancing cardiac care continuity and potentially improving patient outcomes[1][3][5].
Paving the Way for Advanced Heart Failure Management
Cardiosense is also developing an AI algorithm for pulmonary capillary wedge pressure (PCWP), a crucial indicator of heart failure severity. This algorithm, which has 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). Upon regulatory approval for the PCWP Analysis Software, the algorithm will be paired with the CardioTag device for advanced heart failure management[1][3][5].
With the FDA clearance, the Cardiosense CardioTag device marks a significant advancement in wearable, noninvasive cardiac monitoring technology[1][3][5].
| Aspect | Traditional Methods | Cardiosense CardioTag Innovation | |--------------------------------|----------------------------------------|----------------------------------------------------| | Signals captured | Mostly ECG (electrical heart signals) | ECG + PPG (blood flow) + SCG (mechanical activity) | | Cardiac physiological insight | Electrical activity and rhythm analysis| Adds cardiac mechanics, blood flow, timing intervals| | Measurement of LVET | Limited/non-direct | Accurate and noninvasive via SCG waveform | | Clinical advantage | Limited cardiac function detail | Comprehensive cardiac function and hemodynamic data | | Monitoring environment | Mostly clinical/hospital settings | From hospitals to home use |
Sources: [1] Cardiosense. (n.d.). Press release: Cardiosense announces FDA clearance of the CardioTag device for noninvasive hemodynamic monitoring
[3] Cardiosense. (n.d.). Seismocardiography
[5] Cardiosense. (n.d.). Cardiotag
- The Cardiosense CardioTag device, with its innovative approach to wearable, noninvasive cardiac monitoring, represents a significant leap forward in the field of digital health, revolutionizing patient care.
- By providing comprehensive data on cardiac function, hemodynamics, and volume status through the simultaneous capture of Electrocardiogram (ECG), Photoplethysmogram (PPG), and Seismocardiogram (SCG) signals, the Cardiosense CardioTag device expands the scope of science in medical-conditions and health-and-wellness, particularly cardiovascular-health.
- The incorporation of Artificial Intelligence (AI) by Cardiosense in developing an algorithm for pulmonary capillary wedge pressure (PCWP) estimation is a testament to their commitment to technology and improving cardiovascular-health, leading to advanced heart failure management.
- The Cardiosense CardioTag device, with its multimodal sensing capabilities and potential for AI integration, offers a promising intervention in the realm of medical-conditions and health-and-wellness, promoting better outcomes for patients through personalized therapy and early detection of cardiac dysfunction.
