Medical AI company Cardiosense has received 510(k) clearance from the U.S. Food and Drug Administration for its CardioTag device, marking a significant advancement in noninvasive cardiac monitoring technology. The wearable sensor represents the first device capable of simultaneously collecting electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals, enabling comprehensive assessment of both cardiac rhythm and mechanical function.
Revolutionary Multimodal Monitoring Approach
The CardioTag device addresses a critical limitation in current cardiac monitoring by expanding beyond traditional ECG-focused approaches. "Traditionally, noninvasive cardiac monitoring has primarily focused on ECG and rhythm analysis," said Amit Gupta, co-founder and CEO of Cardiosense. "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."
The FDA clearance authorizes the CardioTag device for noninvasive measurement of SCG, ECG, and PPG signals, along with heart rate and pulse rate monitoring. Seismocardiography represents a particularly innovative component, measuring subtle vibrations on the chest wall associated with cardiac mechanical activity—data previously obtainable only through invasive procedures.
Clinical Validation and AI Integration
Clinical studies conducted by Cardiosense have demonstrated that analyzing SCG waveforms alongside ECG and PPG signals enables accurate assessment of cardiac timing intervals, including left ventricular ejection time (LVET), a key indicator of cardiac pumping efficiency. The company plans to begin pilot programs pairing the device with AI algorithms built on the physiological signals collected by CardioTag.
"The CardioTag clearance marks a pivotal step toward clinical adoption and broader access to pressure-guided treatment," said Andrew Carek, co-founder and CTO. "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 algorithm."
Breakthrough Performance in Heart Failure Management
The clinical significance of Cardiosense's technology was demonstrated in a recent prospective, multicenter study published in the Journal of the American College of Cardiology: Heart Failure and presented at the American Heart Association's 2024 Scientific Sessions. The study showed that Cardiosense's AI algorithm for pulmonary capillary wedge pressure (PCWP), which received FDA Breakthrough Device designation, could estimate pressure values in heart failure patients with reduced ejection fraction with accuracy comparable to implantable hemodynamic monitors.
This breakthrough addresses a critical need in heart failure management, where accurate hemodynamic assessment has traditionally required invasive catheterization or implantable devices. Upon regulatory approval for the PCWP Analysis Software, the algorithm will be paired with the CardioTag device for advanced heart failure management.
Transforming Cardiovascular Care Delivery
The CardioTag clearance reflects broader changes in cardiovascular care, where wearable sensors and artificial intelligence are enabling continuous, noninvasive monitoring outside traditional healthcare settings. "This is a deeply meaningful milestone," said Omer Inan, Ph.D., co-founder and chief scientific officer. "For over a decade, we've worked to turn a bold idea into a clinically reliable, noninvasive technology that truly meets patients where they are. With FDA clearance, we're taking a major step toward bringing precision hemodynamic insights into everyday patient care—no matter the setting."
The technology represents a significant evolution from basic fitness trackers to clinically relevant cardiac monitoring devices. By combining multiple physiological signals with machine learning capabilities, CardioTag offers physicians new tools to detect early signs of heart failure, monitor fluid overload, and potentially anticipate cardiac decompensation before traditional methods would identify these changes.
As remote care and hospital-at-home models gain traction, the ability to continuously assess cardiac health without hospitalization could play a major role in managing chronic disease, reducing readmissions, and improving patient outcomes. The FDA clearance positions CardioTag to accelerate this shift, bringing sophisticated cardiac monitoring capabilities into everyday clinical practice and patient care environments.
