FDA OKs Cardiosense’s CardioTag for Advanced Cardiac Function Monitoring

Cardiosense has received U.S. Food and Drug Administration (FDA) 510(k) clearance for CardioTag, a multimodal, wearable sensor that simultaneously captures high-fidelity electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals.

In addition to authorization for measurement of SCG, ECG, and PPG signals, CardioTag is cleared to measure heart rate and pulse rate.

The noninvasive SCG technique measures subtle vibrations on the chest related to cardiac mechanical activity. Cardiosense said studies have shown analyzing the SCG waveform alongside ECG and PPG signals can be used to accurately assess cardiac timing intervals like left ventricular ejection time (LVET) compared to the current standard of care.

The company will begin exploring pilots with CardioTag paired with artificial intelligence (AI) algorithms using the SCG, ECG, or PPG data from the device.

“Our team is thrilled to achieve this critical milestone as part of our mission to advance cardiac care,” said Amit Gupta, Co-Founder and CEO of Cardiosense. “Traditionally, noninvasive cardiac monitoring has primarily focused on ECG and rhythm analysis. With the CardioTag device, we are adding an entirely new dimension by also capturing physiological data on cardiac mechanics and blood flow, providing unprecedented visibility into a patient’s cardiac function, hemodynamics, and volume status.”

A recent study showed Cardiosense’s AI algorithm for PCWP (Pulmonary Capillary Wedge Pressure) could estimate PCWP values with accuracy on par with implantable hemodynamic sensors in patients with heart failure with reduced ejection fraction (HFrEF). Once the PCWP analysis software is approved, the algorithm will be paired with CardioTag to manage advanced heart failure.

“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. “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.”

Last month, the company launched SEISMIC-HF II, a U.S. study to validate its machine learning algorithm for assessing intracardiac filling pressure.