Tag: Stereotaxis

Stereotaxis Announces EU Launch and 510(k) Submission for Synchrony System to Modernize Interventional Cath Labs

ST. LOUIS, Oct. 15, 2025 (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 to the FDA in the US for the Synchrony™ system. Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony’s slim and stunning 55” 4K ultra-high-definition display consolidates the viewing and control of all disparate systems in the lab, offering an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment. Synchrony digitizes the video streams with full fidelity and less than a single frame latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced in the future. Synchrony is made available with SynX™, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab. “In my role managing the technology across our electrophysiology labs and advising labs across the country, I have significant experience with the various interventional lab display offerings,” said Matthew Dare, CEPS, Research and Technology Coordinator, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. “The underlying hardware and software architecture of Synchrony and SynX is far beyond what anyone else has developed. It promises a better intraoperative experience for physicians and nurses, improved equipment reliability and maintenance, and attractive tools for managing a cardiovascular program with remote monitoring, collaboration and recordings.” “We have long recognized the importance of remote connectivity and collaboration for our EP labs,” said Dr. Jim Cheung, Professor of Medicine and Director of Cardiac Electrophysiology Fellowship and Research at Weill Cornell Medicine in New York City. “Technologies to date though have not made reliable high-quality connectivity easy. SynX provides a much-needed solution that can permit seamless collaboration across labs and enhance our ability to ensure the best patient care and to train the next generation of physicians.” Synchrony and SynX have been engineered to be foundational platforms for future innovations. The advanced architecture enables future applications and the leveraging of artificial intelligence for enhanced clinical insights, automation, and safety. “Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities,” said David Fischel, Stereotaxis Chairman and CEO. “The technology improves the robotic cockpit, and will be critical in supporting future robotic efforts for remote long-distance procedures and automated catheter navigation. The opportunity is much broader than robotic labs as we believe all cath labs stand to benefit from improved workflow, connectivity, and collaboration.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, including statements regarding the completion of the Company’s offering and the anticipated use of proceeds therefrom, usually containing 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 would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. There can be no assurance that the Company will recognize revenue related to customer purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com

Stereotaxis and CardioFocus Collaborate to Advance Robotic Pulsed Field Ablation for Cardiac Arrhythmias

ST. LOUIS and MARLBOROUGH, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, and CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac arrhythmias, today announced they have entered into a Collaboration Agreement to advance robotic Pulsed Field Ablation (PFA) technology towards commercialization.

Erasmus Medical Center Advances Cardiovascular Care with Genesis Robotic System

ST. LOUIS, Sept. 22, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced successful first procedures by physicians at Erasmus University Medical Center in Rotterdam, The Netherlands, using the advanced Genesis Robotic Magnetic Navigation System. “We have long recognized the clinical benefits of robotics, and are delighted to be the first in The Netherlands to make the Genesis robotic system available to cardiovascular patients,” said Dr. Sing-Chien Yap, Director of Electrophysiology at Erasmus Medical Center. “We are impressed with the speed and responsiveness of Genesis. Combined with the MAGiC Catheter we are particularly pleased with the synergistic additive improvements to robotic magnetic navigation. These technological advances are important in ensuring we can offer the best care to all arrhythmia patients, including children, patients with congenital heart disease, and patients with complex arrhythmia.” Erasmus MC has been a global leader in using robotic magnetic navigation for complex arrhythmia procedures, having performed over 4,500 procedures with Stereotaxis technology. The Genesis System is the latest advancement in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmia may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “We appreciate our long-term partnership with the electrophysiology team at Erasmus,” said David Fischel, Stereotaxis Chairman and CEO. “We look forward to continuing to support their successful robotic program and working together to advance technological progress, scientific discovery, and clinical care.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com This press release includes statements that may constitute “forward-looking” statements, usually containing 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 would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements 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 commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com

First US Commercial Robotic HD Mapping Procedures Successfully Completed with MAGiC Sweep Catheter

Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the successful completion of the world’s first procedures using MAGiC Sweep™, the first and only robotically-navigated high-density electrophysiology (EP) mapping catheter. The procedures were performed by Dr. Raffaele Corbisiero and Dr. Pedram […]

First US Commercial Robotic HD Mapping Procedures Successfully Completed with MAGiC Sweep Catheter

ST. LOUIS, Sept. 02, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the successful completion of the world’s first procedures using MAGiC Sweep™, the first and only robotically-navigated high-density electrophysiology (EP) mapping catheter. The procedures were performed by Dr. Raffaele Corbisiero and Dr. Pedram Kazemian at Deborah Heart and Lung Center in Browns Mills, New Jersey.

Stereotaxis Announces $12.5 Million Registered Direct Offering of Common Stock

ST. LOUIS, July 17, 2025 (GLOBE NEWSWIRE) — Stereotaxis, Inc. (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it has entered into definitive agreements with investors for the sale of approximately $12.5 million of its shares of common stock in a registered direct offering, at a price per share of $2.00. The financing is being led by a strategic industry partner along with participation from a select group of institutional investors.

First Clinical Results from MAGiC Catheter Study Published in the Journal of Interventional Cardiac Electrophysiology

ST. LOUIS, July 01, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the publication of initial clinical results using the MAGiC catheter in the Journal of Interventional Cardiac Electrophysiology. Titled “First In‑Human Results of the MAGiC Robotic Magnetic Navigation Radiofrequency Ablation Catheter,” the publication is the first peer-reviewed literature supporting the efficacy and safety of Stereotaxis’ MAGiC catheter.

Stereotaxis to Report First Quarter 2025 Financial Results on May 12, 2025

ST. LOUIS, April 22, 2025 (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 2025 first quarter on Monday, May 12, 2025 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.