FDA Clears Cara Medical’s CTA-Based Platform for Cardiac Conduction System Visualization

February 27, 2026—Cara Medical Ltd. announced that the FDA has granted 510(k) clearance for the Cara system, a CTA-based platform that provides noninvasive, patient-specific three-dimensional (3D) visualization of the cardiac conduction system.

Cara Medical stated that it expects to begin its United States commercial launch of the Cara system in the coming months. The company noted that it received FDA Breakthrough Device designation for the Cara system in 2025.

According to the company, the Cara system enables visualization of 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.

The company noted that the interventions include percutaneous or surgical procedures such as transcatheter aortic valve replacement, and procedures to deliver therapy to the patient’s cardiac conduction system or to a targeted location within it, including conduction system pacing.

The Cara system’s two core components are the Metis simulator, a preprocedural planning software, and the Atlas navigator, an intraprocedural guidance platform, which are described in the press release as follows:

• Metis utilizes CTA-based anatomical landmarks to identify the cardiac conduction axis and generate a personalized 3D map of the patient’s cardiac conduction system.
• Atlas overlays the patient-specific conduction system model generated by the Metis onto live fluoroscopic images to assist physicians during image-guided interventions.