FDA grants approval for the CardioTag Device by Cardiosense
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Cardiosense for their innovative wearable sensor, the CardioTag device. This device captures high-fidelity Electrocardiogram (ECG), Photoplethysmogram (PPG), and Seismocardiogram (SCG) signals, marking a significant stride in noninvasive cardiac monitoring.
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). SCG, a noninvasive technique that measures subtle vibrations on the chest wall associated with cardiac mechanical activity, adds a new dimension to cardiac monitoring that complements electrical and blood flow signals captured by ECG and PPG, respectively.
The FDA clearance specifically authorizes the device to measure SCG, ECG, and PPG signals as well as heart rate (HR) and pulse rate (PR), enabling accurate evaluation of cardiac timing intervals such as LVET, a key indicator of cardiac pumping efficiency.
Cardiosense plans to integrate these physiological signals with advanced AI algorithms to develop predictive cardiovascular parameters, such as pulmonary capillary wedge pressure (PCWP). This positions the device as foundational for building a noninvasive cardiac AI platform supporting precision cardiovascular care.
The CardioTag’s clinical implications include early detection of cardiac disease, guiding personalized therapies, and improving patient outcomes across healthcare settings. Amit Gupta, Co-founder and CEO of Cardiosense, stated that the CardioTag device provides unprecedented visibility into a patient's cardiac function, hemodynamics, and volume status.
In a promising development, Cardiosense will begin exploring pilots with the CardioTag device paired with AI algorithms using the SCG, ECG, or PPG data from the device. Furthermore, the CardioTag device, initially authorized for noninvasive measurement of SCG, ECG, PPG signals, heart rate (HR), and pulse rate (PR), is now set to be used for advanced heart failure management with the addition of the PCWP Analysis Software. Upon regulatory approval for the PCWP Analysis Software, the algorithm will be paired with the CardioTag device for advanced heart failure management.
The AI algorithm for PCWP received FDA Breakthrough Device designation, signifying its potential to significantly improve patient care. Omer Inan, PhD, Co-founder and Chief Scientific Officer at Cardiosense, stated that the FDA clearance marks a deeply meaningful milestone in bringing precision hemodynamic insights into everyday patient care.
The CardioTag device continues to play a foundational role in building a comprehensive noninvasive cardiac AI platform. The device's ability to measure various physiological signals and its potential integration with AI algorithms for parameters like PCWP positions it at the forefront of transforming cardiovascular disease management.
Andrew Carek, Co-founder and CTO of Cardiosense, expressed excitement for the potential role of the CardioTag device in developing AI models for parameters like pulmonary capillary wedge pressure (PCWP). The Cardiosense medical AI company is advancing cardiovascular disease management through the development of AI algorithms for parameters like PCWP.
A prospective, multicenter study has demonstrated that Cardiosense's AI algorithm for PCWP can estimate PCWP values with accuracy comparable to implantable hemodynamic sensors in patients with heart failure with reduced ejection fraction (HFrEF). This is a significant step toward the development of a noninvasive cardiac AI platform.
In summary, the FDA clearance of CardioTag marks a significant innovation by combining SCG with established monitoring modalities, offering unprecedented, multimodal cardiac function data that could transform heart disease management through enhanced diagnosis, personalized treatment, and continuous monitoring. The CardioTag device, with its potential integration with AI algorithms for various cardiovascular parameters, is poised to revolutionize cardiovascular disease management.
The FDA clearance authorizes the CardioTag device to measure Scientific signals such as SCG, ECG, and PPG, in addition to heart rate (HR) and pulse rate (PR), enhancing Health-and-wellness assessments, particularly with regard to cardiovascular-health. With the integration of Artificial-Intelligence algorithms, the device is intended to develop predictive cardiovascular parameters, such as pulmonary capillary wedge pressure (PCWP), to provide Precision care for heart failure management. The potential to revolutionize medical-conditions management, including early detection and personalized therapies for cardiac diseases, is a promising outcome of this technological advancement.
