Stereotaxis, a pioneer in surgical robotics for minimally invasive endovascular procedures, has announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The MDR replaces the former European Medical Device Directive and includes more stringent standards and requirements in quality, clinical, and post-market surveillance areas.
The recertification under the MDR covers all Stereotaxis devices currently available in Europe, indicating that the company’s Quality Management System is in accordance with the new regulations. This certification is a reflection of Stereotaxis’ commitment to providing high-quality devices, systems, and processes to ensure the best possible experience for patients and physicians relying on their technology.
With the updated CE Mark, Stereotaxis will be able to support regulatory clearances for upcoming innovations in the field of surgical robotics. This achievement is the culmination of several years of diligent work by the Stereotaxis team, and the company acknowledges the collaboration with their Notified Body throughout the entire certification process.
“We are proud to have reached this milestone and to be in compliance with the new MDR,” said Matthew Stepanek, Sr. Director of Regulatory Affairs, Quality & Technical Writing at Stereotaxis. “This certification ensures that our products adhere to the highest standards of quality and safety, further enhancing our mission to provide unsurpassed patient care with robotic precision.”
David Fischel, Chairman, and CEO of Stereotaxis, congratulated the team for their hard work and dedication in achieving this recertification. He emphasized that this accomplishment solidifies the company’s commitment to delivering innovative surgical robotics solutions and improving clinical safety for patients globally.
Stereotaxis is a global leader in surgical robotics and has helped treat over 100,000 patients worldwide. Their technology enables physicians to perform minimally invasive interventions with precision and safety while enhancing connectivity and intelligence in the operating room. For more information about Stereotaxis and their innovative solutions, please visit their official website at www.Stereotaxis.com.
Stereotaxis, a pioneer in surgical robotics for minimally invasive endovascular procedures, has recently announced that it has received CE Mark recertification under the new European Medical Device Regulation (MDR). The MDR has replaced the former European Medical Device Directive and introduces stricter standards and requirements in quality, clinical, and post-market surveillance areas.
This recertification under the MDR signifies that Stereotaxis’ devices in Europe comply with the new regulations, highlighting the company’s commitment to providing high-quality devices, systems, and processes to ensure optimal outcomes for patients and physicians.
With the updated CE Mark, Stereotaxis will be able to seek regulatory clearances for upcoming innovations in the field of surgical robotics. This achievement is the result of several years of dedicated work by the Stereotaxis team, and the company acknowledges the collaboration with their Notified Body throughout the certification process.
Receiving recertification under the MDR is a significant milestone for Stereotaxis, as it ensures that their products meet the highest standards of quality and safety. This further strengthens their mission to provide exceptional patient care with robotic precision.
The CEO of Stereotaxis, David Fischel, commended the team for their hard work and dedication in achieving this recertification. He emphasized that this accomplishment solidifies the company’s commitment to delivering innovative surgical robotics solutions and improving clinical safety for patients worldwide.
Stereotaxis is a global leader in surgical robotics, having treated over 100,000 patients globally. Their technology enables physicians to perform minimally invasive interventions with precision and safety, while also enhancing connectivity and intelligence in the operating room.
While the article does not mention specific market trends or forecasts, the field of surgical robotics is experiencing significant growth. The increased adoption of robotic-assisted procedures, advancements in technology, and the growing demand for minimally invasive interventions are driving the market’s expansion. This trend is expected to continue in the coming years, with the market projected to reach a value of over $11 billion by 2026.
One key challenge associated with surgical robotics is the high cost of these systems. The initial investment and ongoing maintenance expenses can be significant for healthcare institutions. Another challenge is the need for specialized training for physicians and staff to effectively utilize the robotic systems. Additionally, there may be concerns about the autonomy of robotic systems and the potential for errors or malfunctions. These challenges, however, are being addressed through ongoing advancements in technology and increased user training.
For more information about Stereotaxis and their innovative solutions in surgical robotics, please visit their official website at Stereotaxis.com.