The full Stereotaxis lab with the Genesis RMN system. Source: Stereotaxis
Stereotaxis Inc. last week announced that it received CE Mark for its devices in Europe under new European Medical Device Regulation, or EU MDR, framework. The St. Louis, Mo.-based company has developed surgical robotics for minimally invasive endovascular interventions.
The recertification under MDR covers all Stereotaxis devices available in Europe. In 2021, the MDR replaced the EU Medical Device Directive (MDD) with more stringent requirements for 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 also 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 for 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,” stated David Fischel, chair and CEO of Stereotaxis. “Congratulations to all those at Stereotaxis who made this possible.”
“This final step in the certification of 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 affairs, quality, and technical writing at the company. “We appreciate the collaboration with our Notified Body in this entire process.”
Stereotaxis has developed technologies including the Genesis robotic magnetic navigation (RMN) system. It includes robotic precision and safety for cardiac ablation.
Genesis uses 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, according to Stereotaxis.
The company also offers the Magic magnetic 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.
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Italian hospital establishes cardiac program with Stereotaxis
Stereotaxis recently announced that Hospital Santa Maria della Pietà established the first robotic cardiac heart program in the region of Naples, Italy. Doctors there can now treat patients with heart rhythm disorders using robotic ablation procedures.
The hospital was the first in Italy to adopt the Genesis RMN system, said the company. Flexible, rugged robotic arms hold the agents to increase the potential range of motion and allow for wider X-ray angulation, it explained.
Dr. Mario Volpicelli, head of the hospital’s electrophysiology unit, said Genesis provides “an unprecedented level of precision and control” in cardiac ablation. Volpicelli added that it helps to target arrhythmias accurately while minimizing the risk to patients.
Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice.
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