Stereotaxis obtains updated CE marking for all devices available in Europe

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Last week, Stereotaxis Inc. announced that it has received CE marking for its devices in Europe under Europe’s new medical device regulation, the EU’s MDR. The company based in St. Louis, Missouri, has developed surgical robotics for minimally invasive endovascular procedures.

MDR recertification covers all Stereotaxis devices available in Europe. In 2021, the MDR replaced the EU’s Medical Device Directive (MDD) with more stringent requirements for companies that audit every 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 confirms regulatory approvals for future 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.”

“This latest step in certifying our products and quality systems under MDR is the culmination of several years of diligent work by the Stereotaxis team,” added Matthew Stepanek, senior director of regulatory, quality and technical writing at the company. “We appreciate the cooperation with our notified body throughout the process.”

Stereotaxis has developed technologies including the Genesis robotic magnetic navigation (RMN) system. It covers the robotic precision and safety of cardiac ablation.

Genesis uses smaller magnets that rotate along the center of mass, allowing for quick response to physician inspection. According to Stereotaxis, a smaller system can improve patient comfort, provide greater patient access and increase laboratory space.

The company’s offer also includes the Magic magnetic 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.

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Italian hospital establishes a cardiology program with Stereotaxis

Stereotaxis recently announced that Santa Maria della Pietà Hospital has launched the first robotic heart program in the Naples region of Italy. Doctors there can now treat patients with heart rhythm disorders using robotic ablation procedures.

According to the company, the hospital was the first in Italy to implement the Genesis RMN system. It is explained that the flexible, durable robotic arms maintain means to increase the potential range of motion and enable a wider X-ray angle.

Dr. Mario Volpicelli, head of the hospital’s electrophysiology department, said Genesis provides an “unprecedented level of precision and control” in cardiac ablation. Volpicelli added that this helps to precisely target the arrhythmia while minimizing the risk to patients.

Editor’s note: This article was distributed from Robot report sibling site Mass Device.