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Stereotaxis secures CE Mark recertification under new EU rules

Published 2024-05-24, 12:56 p/m
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ST. LOUIS - Stereotaxis (NYSE: NYSE:STXS), a leader in robotic technologies for endovascular surgery, announced today it has obtained CE Mark recertification for its devices under the European Union's Medical Device Regulation (MDR). The recertification signifies compliance with enhanced standards for quality, clinical, and post-market surveillance in the EU's new regulatory framework.

The MDR, which supersedes the previous Medical Device Directive, aims to establish a more rigorous regulatory environment to ensure the safety and efficacy of medical devices. With the updated EU Quality Management System Certificate now in hand, Stereotaxis' products maintain valid market authorization within the EU.

Matthew Stepanek, Sr. Director of Regulatory Affairs at Stereotaxis, expressed gratification for the collaborative efforts leading to this achievement, stating that the recertification reflects years of dedicated work. David Fischel, Chairman and CEO, highlighted the importance of this milestone in maintaining the company's commitment to high-quality standards for patient and physician care.

Stereotaxis, recognized for its contributions to minimally invasive endovascular intervention, has a history of innovation in the development of robotic systems and solutions. The technology has been utilized in over 100,000 patient procedures worldwide.

The recertification under MDR is also expected to support regulatory clearances for Stereotaxis' forthcoming innovations, potentially broadening the company's impact in the interventional laboratory space.

This announcement is based on a press release statement from Stereotaxis, Inc.

InvestingPro Insights

Stereotaxis' recent CE Mark recertification under the EU's Medical Device Regulation is a significant step for the company, reinforcing its compliance with stringent regulatory standards. This achievement is particularly noteworthy considering the company's financial metrics and market performance as captured by InvestingPro. With a market capitalization of $165.89 million, Stereotaxis is navigating the competitive medical device landscape with a focus on innovation and quality.

An InvestingPro Tip highlights that Stereotaxis is trading at a high Price / Book multiple of 11.33, suggesting a premium valuation relative to the company's book value as of Q1 2024. This could reflect investor confidence in the company's assets and technology, despite the fact that it has not been profitable over the last twelve months. Additionally, analysts do not anticipate the company will turn a profit this year, which is a critical consideration for investors.

From a financial health perspective, Stereotaxis operates with a moderate level of debt and has liquid assets that exceed its short-term obligations. This indicates a degree of financial stability, which may reassure investors in light of the company's operational losses. The InvestingPro Data shows an operating income margin of -77.36% for the last twelve months as of Q1 2024, underscoring the company's current challenges in generating profit from its operations.

For those interested in a deeper analysis, there are additional InvestingPro Tips available that could provide further insights into Stereotaxis' performance and outlook. By using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to these valuable tips.

As Stereotaxis continues to navigate the medical device industry, these real-time data points and expert insights from InvestingPro are essential for investors looking to understand the company's financial health and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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