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Stereotaxis wins updated CE mark for all devices available in Europe

Stereotaxis (NYSE:STXS) announced today that it received CE mark for its devices in Europe under new European Medical Device Regulation (EU MDR) framework.

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.

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.”

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