FDA clears AI-powered platform that personalizes care during TAVR, cardiac pacing procedures
Cara Medical, a medtech company focused on advanced imaging technologies, has secured U.S. Food and Drug Administration (FDA) clearance for its new platform that noninvasively visualizes a patient’s cardiac conduction system.
The CARA System, which previously earned the FDA’s breakthrough device designation, was designed to help interventional cardiologists and electrophysiologists plan ahead before procedures and then guide them during treatment. It can be used for structural heart interventions such as transcatheter aortic valve replacement (TAVR) as well as pacing procedures.
The newly cleared system includes two primary components. The CARA Metis Simulator is a preprocedural planning software that identifies the cardiac conduction axis on CT angiography results and generates a 3D map of the patient’s conduction system. The CARA Atlas Navigator, meanwhile, overlays that map onto live fluoroscopic images to assist with intraprocedural guidance.
Artificial intelligence (AI) algorithms play a role in both components, extracting metadata and detecting the user’s catheter for visualization, but all AI calculations can still be confirmed by a physician.
With TAVR now established as the go-to treatment option for many patients who present with severe aortic stenosis, the CARA System’s ability to provide guidance during those procedures has received a significant amount of attention from research teams.
One 2025 analysis in Heart Rhythm, for example, found that using this technology may help reduce the risk of permanent pacemaker implantation.[1] A separate study in Structural Heart highlighted the CARA System’s potential to anticipate TAVR risks in advance.[2]
“This FDA clearance represents a significant milestone for Cara Medical,” Shlomo Ben-Haim, MD, founder and chairman of Cara Medical, said in a statement. “We look forward to launching the product in the United States and providing physicians with a validated tool designed to enhance visualization of the cardiac conduction axis. Our growing body of clinical publications highlights Cara's potential role in supporting procedural precision during TAVR and other valve interventions, and in facilitating physiologic lead targeting during conduction system pacing.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.