Cardiosense has received the US Food and Drug Administration (FDA) 510(k) approval for its CardioTag device, a multimodal, wearable sensor designed for advanced cardiac function monitoring.
The CardioTag device integrates multiple sensing technologies, offering a comprehensive non-invasive solution to assess cardiac function.
It can be used by AI algorithms to evaluate cardiac pressures and volume status.
The CardioTag device measures seismocardiogram (SCG), electrocardiogram (ECG), and photoplethysmogram (PPG) signals, heart rate and pulse rate.
SCG is a non-invasive method that detects subtle chest wall vibrations linked to cardiac mechanical activity.
Cardiosense co-founder and CEO 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.”
According to clinical studies, combining SCG, ECG, and PPG signals can accurately assess cardiac timing intervals, such as left ventricular ejection time, compared to current standards.
Cardiosense plans to initiate pilot programmes using the CardioTag device paired with AI algorithms that analyse SCG, ECG, or PPG data.
A recent multicentre study, published in the Journal of the American College of Cardiology: Heart Failure, highlighted the accuracy of Cardiosense’s AI algorithm.
The algorithm enabled pulmonary capillary wedge pressure (PCWP) estimation, comparable to implantable hemodynamic sensors in heart failure patients with reduced ejection fraction.
The CardioTag device is the result of extensive clinical research across biomedical engineering, cardiovascular medicine, and data science.
Cardiosense co-founder and CTO Andrew Carek said: “The CardioTag clearance marks a pivotal step toward clinical adoption and broader access to pressure-guided treatment.
“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 is a medical AI company focused on transforming cardiovascular disease management through novel wearable sensors and machine learning algorithms.
The company aims to detect early cardiac disease signs, guide personalised therapy, and enhance patient outcomes.
Cardiosense co-founder and chief scientific officer Omer Inan said: “This is a deeply meaningful milestone. For over a decade, we’ve worked to turn a bold idea into a clinically reliable, non-invasive 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.”
