The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardioTag, Cardiosense’s multimodal, wearable sensor.
Aimed at cardiac function monitoring, the device is said to capture high-fidelity electrocardiogram (ECG), seismocardiogram (SCG), and photoplethysmogram (PPG) signals.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
SCG is a technique that detects subtle chest wall vibrations linked to the heart’s mechanical activity.
The clearance permits the use of the device for the noninvasive measurement of these signals, alongside pulse rate (PR) and heart rate (HR).
Cardiosense’s trials have shown that the combined analysis of SCG waveforms with ECG and PPG signals can determine cardiac timing intervals such as left ventricular ejection time (LVET).
The company is set to initiate pilot trials using the device in conjunction with AI algorithms that utilise the data from ECG, PPG or SCG signals.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataCardiosense noted that a recent multi-centre, prospective trial highlighted that the algorithm for pulmonary capillary wedge pressure (PCWP) could estimate PCWP values with precision comparable to implantable haemodynamic sensors in heart failure patients who have reduced ejection fraction (HFrEF).
This AI algorithm, which has received the agency’s breakthrough device designation, is expected to be coupled with the device for enhanced management of advanced heart failure upon regulatory clearance of the PCWP Analysis Software.
The development of the device is grounded in clinical research and interdisciplinary innovation, encompassing cardiovascular medicine, biomedical engineering and data science.
Cardiosense CEO and co-founder Amit Gupta said: “Our team is thrilled to achieve this critical milestone as part of our mission to advance cardiac care. 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.”
