Medical AI company Cardiosense has claimed FDA clearance for its CardioTag device, a wearable sensor that provides a noninvasive approach to monitoring cardiac function.
The company says it's the first multimodal, wearable sensor that simultaneously captures high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals.
The FDA clearance authorizes the CardioTag device for noninvasive measurement of SCG, ECG and PPG signals as well as heart rate and pulse rate.
The company says the CardioTag device was built on more than a decade of clinical and scientific research to develop novel wearable sensors and machine learning algorithms that translate raw physiological signals into clinically actionable parameters. These insights can help detect early signs of cardiac disease, guide personalized therapy and improve patient outcomes, the company said.
Seismocardiogram (SCG) is a noninvasive technique that measures subtle vibrations on the chest wall associated with cardiac mechanical activity. Clinical studies conducted by Cardiosense have demonstrated that analyzing the SCG waveform alongside ECG and PPG signals can be used to accurately assess cardiac timing intervals such as left ventricular ejection time (LVET)—a measure of how efficiently the heart is pumping blood—compared to the current standard-of-care.
Cardiosense plans to launch pilots with the CardioTag device paired with AI algorithms using the SCG, ECG or PPG data from the device.
“The CardioTag clearance marks a pivotal step toward clinical adoption and broader access to pressure-guided treatment,” said Andrew Carek, co-founder and CTO of Cardiosense, in a statement. “We’re excited for the foundational role that the CardioTag device will play in building a noninvasive cardiac AI platform, as the signals it collects provide a rich data input upon which AI models for cardiovascular parameters can be developed, such as our pulmonary capillary wedge pressure (PCWP) algorithm.”
Cardiosense’s AI algorithm for PCWP previously received FDA Breakthrough Device designation.
A recent prospective, multicenter study, published in the Journal of the American College of Cardiology: Heart Failure and presented as Late-Breaking Science at the American Heart Association’s 2024 Scientific Sessions, demonstrated that Cardiosense's algorithm could estimate PCWP values with accuracy on par with implantable hemodynamic sensors in patients with heart failure with reduced ejection fraction.
Once the PCWP analysis software gains regulatory approval, Cardiosense plans to pair the algorithm with the CardioTag device for advanced heart failure management.