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Stereotaxis Achieves CE Mark in Europe and Submits 510(k) in the US for Next Generation Robotic System GenesisX
GlobeNewswire News Room· 2024-08-12 20:03
Latest innovation in Robotic Magnetic Navigation technology supports broad accessibility of robotics for minimally-invasive endovascular surgery GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States ST. LOUIS, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Europe and submitted a 510(k) application ...
Stereotaxis to Report Second Quarter 2024 Financial Results on August 12, 2024
GlobeNewswire News Room· 2024-07-22 20:05
ST. LOUIS, July 22, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it will release financial results for its 2024 second quarter on Monday, August 12, 2024 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. EST that day to discuss the Company's results and corporate developments. What: Stereotaxis second quarter 2024 financial r ...
Stereotaxis Strengthens Board of Directors with Appointment of Nachum Shamir
GlobeNewswire News Room· 2024-07-18 20:13
ST. LOUIS, July 18, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced the appointment of Nachum "Homi" Shamir to its Board of Directors. Mr. Shamir most recently served as Chairman and Chief Executive Officer of Luminex Corporation from 2014 through its sale to DiaSorin S.p.A. for $1.8 Billion in 2021. Prior to Luminex, Mr. Shamir served as President and Chief Executive Officer of Given Imaging from 2006 throug ...
Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment
globenewswire.com· 2024-05-29 12:25
ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the ...
Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment
Newsfilter· 2024-05-29 12:25
ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the ...
Stereotaxis (STXS) Gets CE Recertification for Approved Products
zacks.com· 2024-05-27 15:51
Stereotaxis (STXS) a pioneer in surgical robotics for minimally invasive endovascular intervention, recently announced its successful recertification under the European Union's Medical Device Regulation (MDR). This significant milestone, which covers all Stereotaxis devices currently available in Europe, marks a crucial advancement in the company's pursuit of excellence in the surgical robotics market. The News in Detail The MDR (Regulation (EU) 2017/745) replaces the previous European Medical Device Direct ...
Stereotaxis' (STXS) RMN System to Aid in Treating Arrhythmias
zacks.com· 2024-05-24 17:36
Stereotaxis (STXS) recently announced that the first robotic cardiac heart program in Southern Italy had been developed at Hospital Santa Maria della Pietà, Nola. With the help of this cutting-edge technology, patients with heart rhythm abnormalities can now be effectively treated with robotic ablation treatments. Hospital Santa Maria della Pietà is the first hospital in Italy to use the latest generation of Genesis Robotic Magnetic Navigation (RMN) system. Price Performance For the past six months, STXS's ...
Stereotaxis Receives CE Mark Recertification Under EU's MDR Regulatory Framework
Newsfilter· 2024-05-24 12:37
MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certific ...
Stereotaxis Receives CE Mark Recertification Under EU's MDR Regulatory Framework
globenewswire.com· 2024-05-24 12:37
ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union's new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed ...
Stereotaxis Makes A Strategic Acquisition Bolstering Its Future
seekingalpha.com· 2024-05-23 08:38
Stereotaxis Reports Solid Results We must contextualize Stereotaxis' (NYSE:STXS) reported results until their new products get approved. The company will have limited sales growth and a modest cash burn in the meantime. This doesn't mean we shouldn't analyze the current business. It just shouldn't be where the majority of our focus lies. I have fairly low expectations for the existing business, but very high expectations for the medium term (next ~2 years). With that in mind, let's briefly look at the Q1 re ...