FDA Clears Wearable CardioTag Device for Advanced Heart Monitoring
FDA Clears Wearable CardioTag Device for Advanced Heart Monitoring
Source: JACC , July 27, 2025
1. What is CardioTag?
• A new wearable heart sensor developed by Cardiosense.
• Recently received FDA clearance.
2. What Makes It Unique?
• Simultaneously captures three types of signals:
• ECG (electrical activity)
• PPG (blood flow)
• SCG (cardiac mechanical vibrations)
• Also measures:
• Heart rate
• Pulse rate
When the article refers to CardioTag capturing “blood flow,” it primarily means:
• Identifying changes in blood volume and pulse waveform using Photoplethysmogram (PPG) signals
• PPG uses light to measure how blood volume pulses through peripheral tissue (e.g., wrist, fingertip), indirectly reflecting hemodynamic status, such as pulse rate and perfusion
• Combined with SCG (mechanical vibrations) and ECG (electrical signals), CardioTag gives insight into how well the heart is pumping and how blood is flowing through the cardiovascular system—without invasive sensors.
3. Role of AI:
• Can be paired with AI algorithms to assess:
• Cardiac mechanics
• Hemodynamics (blood pressure/flow)
• Volume status
• Potentially detect heart failure signs earlier
4. Clinical Potential:
• A study in JACC: Heart Failure showed that CardioTag + Cardiosense AI could estimate pulmonary capillary wedge pressure (PCWP) with near-implantable accuracy.
• This could offer noninvasive alternatives for monitoring advanced heart failure patients.
5. What’s Next?
• Cardiosense is awaiting FDA clearance for its PCWP Analysis software, aiming to launch it as part of the CardioTag system.
