FDA Clears CTA-Based Cardiac Conduction System Visualization Tech

Cara Medical Ltd. has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for the CARA System, a computed tomography angiography (CTA)-based platform that provides noninvasive, patient-specific three-dimensional (3D) visualization of the cardiac conduction system.

Earning FDA Breakthrough Device Designation last year, the CARA System enables clinicians to visualize the location of the cardiac conduction system relative to surrounding cardiac structures during structural heart and pacing procedures.

The system is intended for the preplanning and guidance of medical interventions in areas known to contain or be adjacent to the cardiac conduction system. These include percutaneous or surgical procedures such as transcatheter aortic valve replacement (TAVR), as well as procedures in which physicians seek to deliver therapy to the patient’s cardiac conduction system or to a targeted location within it, including conduction system pacing (CSP).

The CARA System integrates two core components:

• CARA Metis Simulator: A preprocedural planning software that uszes CTA-based anatomical landmarks to identify the cardiac conduction axis and generate a personalized 3D map of the patient’s cardiac conduction system.
• CARA Atlas Navigator: An intraprocedural guidance platform that overlays the patient-specific conduction system model generated by the Metis onto live fluoroscopic images to assist physicians during image-guided interventions.

“This FDA clearance represents a significant milestone for Cara Medical,” Cara Medical Founder/Chairman Shlomo Ben-Haim, M.D., said. “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 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.”

The CARA System operates on a standard workstation platform, integrates with existing fluoroscopy systems, and does not have direct patient contact. The system utilizes advanced image processing and AI/ML-based algorithms to support CT segmentation, fluoroscopic metadata extraction, and catheter detection, with all outputs subject to physician review and confirmation.

The company expects to begin its U.S. commercial launch in the next few months.

Cara Medical develops advanced imaging software designed to noninvasively localize the cardiac conduction system using a patient’s CT angiography. The company’s technology is intended to support procedural precision in cardiac interventions requiring a detailed understanding of the conduction pathway, particularly in conduction system pacing and structural heart procedures, including TAVR, transcatheter mitral valve replacement (TMVR), and transcatheter tricuspid valve replacement (TTVR).