FDA Clears Stereotaxis’ Magnetic Ablation Catheter, Strengthening Robotic EP Strategy

Stereotaxis has secured U.S. Food and Drug Administration approval for its robotically navigated magnetic ablation catheter, a milestone that allows the company to replace an older Johnson & Johnson device previously used with its robotic systems. The newly approved Magic catheter will be marketed alongside Stereotaxis’ GenesisX robotic electrophysiology platform, which received 510(k) clearance last year and has been in a limited rollout.

The catheter is designed for use in ablation procedures to treat cardiac arrhythmias, enabling physicians to precisely guide the device using a computer-controlled robotic interface. The FDA authorized the catheter for cardiac mapping, diagnostic pacing and lesion creation to treat supraventricular tachycardia, particularly in patients with congenital heart disease where manual catheter navigation is challenging.

By launching its own catheter, Stereotaxis aims to reduce reliance on J&J, improve clinical performance and expand its disposables business, creating a recurring revenue stream to support broader adoption of its robotic systems.

12-01-2026