Stereotaxis obtains updated CE marking for all devices in Europe

Stereotaxis (NYSE:STXS) today announced that it has received CE marking for its devices in Europe under the new European Medical Devices Regulation (EU MDR).

MDR recertification covers all Stereotaxis devices available in Europe.

In 2021, the EU’s MDR replaced the EU’s Medical Device Directive (MDD) with stricter requirements for companies that audit each device, also known as notified bodies. The change applies not only to devices that are new to the EU market, but also to those that have entered the market under MDD and must undergo recertification under MDR to remain on sale.

Stereotaxis stated that it now has an updated EU Quality Management System Certificate. This proves that the company complies with MDR requirements and that its products now have a valid CE mark. MDR certification also validates regulatory approvals for upcoming innovations.

“This is a reflection of Stereotaxis’ commitment to high-quality devices, systems and processes to provide the best possible experience for patients and physicians using our technology,” said David Fischel, president and CEO of Stereotaxis. “Congratulations to everyone at Stereotaxis who made this possible.”

Stereotaxis is developing a range of technologies, including the Genesis robotic magnetic navigation (RMN) system. RNM uses robotic precision and safety during cardiac ablation. Genesis uses smaller magnets that rotate along the center of mass, allowing for quick response to physician commands. A smaller system can improve patient comfort, provide greater patient access, and increase laboratory space.

The company also has the Magic magnetic ablation catheter. Magic is a robotic catheter that enables minimally invasive cardiac ablation procedures. In March, Stereotaxis submitted it for approval in Europe and the US.