Admin_Adham
The US Food and Drug Administration has given 510(k) clearance for CardioTag, a wearable sensor designed for cardiovascular monitoring.
The device includes an ECG, photoplethysmogram, and seismocardiogram and is also capable of registering the wearer’s heart and pulse rate.
“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, maker of the device, in a statement. “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.”
The FDA decision comes on the heels of recently published study in the Journal of the American College of Cardiology: Heart Failure that demonstrated Cardiosense’s AI algorithm could estimate pulmonary capillary wedge pressure values with accuracy comparable to implantable hemodynamic sensors in patients with heart failure with reduced ejection fraction.
“This is a deeply meaningful milestone,” said Omer Inan, PhD, co-founder and chief scientific officer at Cardiosense, in a statement. “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.”
