Stereotaxis announced today that it received CE mark for its devices in Europe under new European Medical Device Regulation framework. Recertification under MDR covers all Stereotaxis devices available in Europe.
In 2021, EU MDR replaced the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are new to the EU market but those that entered the market under MDD and must be re-certified under MDR to remain available for sale.
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Stereotaxis said it now has an updated EU Quality Management System Certificate. This demonstrates that the company falls in line with MDR and that its products now have valid CE mark. The MDR certification also supports regulatory clearances of upcoming innovations.
“This is a reflection of Stereotaxis’ commitment to high-quality devices, systems, and processes to ensure the best possible experience for the patients and physicians that rely on our technology,” said David Fischel, Stereotaxis chair and CEO. “Congratulations to all those at Stereotaxis who made this possible.”
Stereotaxis develops a number of technologies, including the Genesis robotic magnetic navigation (RMN) system. RNM utilizes robotic precision and safety for cardiac ablation. Genesis utilizes smaller magnets that rotate along their center of mass, allowing for responsiveness to physician control. The smaller system can improve the patient experience, provide greater patient access and increase lab space.
The company also has the Magic magnetic ablation catheter. Magic is a robotically navigated catheter that performs minimally invasive cardiac ablation procedures. Stereotaxis submitted it for European and U.S. approval in March.
