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Investing.com -- Stereotaxis (NYSE:STXS) stock surged 12% after the company received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MAGiC Sweep catheter, the world’s first robotically navigated high-density electrophysiology mapping catheter.
The MAGiC Sweep represents a significant advancement in technology for diagnosing and treating complex arrhythmia patients. Equipped with 20 electrodes, the device facilitates rapid and detailed electroanatomical mapping of heart chambers while offering extended reach and precision through integration with Stereotaxis’ Robotic Systems.
This FDA clearance marks Stereotaxis’ first approval for an interventional catheter in nearly two decades. The company describes the catheter as having an atraumatic design that prioritizes patient safety while supporting more anatomically accurate maps by avoiding the distension caused by rigid catheters.
Dr. Roderick Tung, Chief of Cardiology at The University of Arizona College of Medicine - Phoenix, highlighted the significance of the development, noting that point-by-point mapping limitations have previously held back robotic navigation adoption in electrophysiology procedures.
Similarly, Dr. Daniel Cooper, Director of Electrophysiology Lab at Washington University, emphasized that combining high-density mapping with robotics represents "an exciting long-awaited milestone for the community of robotic electrophysiologists and the broader EP field."
David Fischel, Stereotaxis Chairman and CEO, called the FDA clearance a "pivotal moment" for the company, adding that the MAGiC Sweep is only the first of multiple robotically-steered interventional devices being developed as part of the company’s innovation strategy.
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