Stereotaxis receives CE mark re-certification under the EU MDR regulatory framework

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular procedures, today announced that it has received CE mark recertification under the European Union’s new medical devices (MDR) regulatory framework. MDR recertification covers all Stereotaxis devices currently available in Europe.

The MDR (Regulation (EU) 2017/745) replaces the previous European Medical Devices Directive, which regulated the approval and placing on the market of medical devices in the EU. The new regulation includes more stringent standards and requirements in the areas of quality, clinical surveillance and post-market surveillance. It aims to create a robust regulatory framework to improve clinical safety and market access for medical devices. Stereotaxis has now received the updated EU Quality Management System Certificate. This certification confirms that the Stereotaxis Quality System is MDR compliant and that Stereotaxis products currently carry a valid CE mark under the MDR. MDR certification will provide the basis for obtaining regulatory approvals for future innovations.

“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,” said Matthew Stepanek, senior director of regulatory, quality and technical writing. “We appreciate the cooperation with our notified body throughout the process.”

“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. “Congratulations to everyone at Stereotaxis who made this possible.”

About stereotaxy
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular procedures. Its mission is to discover, develop and deliver robotic systems, instruments and IT solutions for the interventional laboratory. These innovations help physicians deliver unparalleled patient care with robotic precision and safety, expand access to minimally invasive therapies, and increase productivity, connectivity and intelligence in the operating room. Stereotaxy technology has been used to treat over 100,000 patients in the United States, Europe, Asia and other countries. More information can be found at www.Stereotaxis.com.

This press release contains statements that may constitute “forward-looking” statements, typically including the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that may cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at a sustainable level, market acceptance of the Company’s products, and the impact of global economic conditions on the market. customers’ ability and willingness to purchase its technology, competitive factors, changes resulting from health policy, dependence on third-party suppliers, timing of regulatory approvals, impact of pandemic or other disasters and other risks discussed in the Company’s periodic and other reports with the Securities and Exchange Commission Filing these forward-looking statements, the Company undertakes no obligation to update them for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other obligations because some of these orders and other obligations are subject to contingencies that are beyond the Company’s control and may be changed, modified, delayed or canceled.

Company contact details:
David L. Fischel
President and CEO

Kimberly R. Peery
Chief Financial Officer

314-678-6100
[email protected]