STXS Stereotaxis

Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter

Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter

ST. LOUIS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter.

“FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. It ensures the benefits of Robotic Magnetic Navigation can support patients with complex and critical heart rhythm disorders, represents a major advance in robotic cardiac ablation technology, and provides a foundation for continued technological and clinical progress,” said David Fischel, Stereotaxis Chairman and CEO. “We want to thank and recognize the team members, partners, clinicians and reviewers who made this milestone possible. We look forward to seeing MAGiC serve as a key pillar in our effort to continue making robotics broadly impactful and beneficial in electrophysiology.”

Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The catheter is designed to expand access to minimally-invasive cardiac ablation therapy in complex underserved patient populations. The catheter is navigated by highly-precise computer-controlled magnetic fields, offering levels of catheter maneuverability, precision and stability often not possible with traditional catheters.

“Robotic Magnetic Navigation has played a central role in the treatment of complex arrhythmias, and FDA approval of MAGiC is a critical milestone in the advancement of the technology and ensuring its continued positive impact on the care of challenging electrophysiology patients,” said Dr. J. Peter Weiss, Cardiac Electrophysiologist and Associate Professor of Medicine at Banner University of Arizona Medical Center.

“The MAGiC catheter is an important innovation in the robotic treatment of arrythmias, and will support our efforts to offer safe and effective therapy to otherwise underserved patients,” said Dr. J. David Burkhardt, Cardiac Electrophysiologist, Texas Cardiac Arrhythmia Institute at St. David's Medical Center. “We look forward to using MAGiC, and its unique advantages, to continue pioneering the leading edge of electrophysiology.”

The MAGiC Magnetic Interventional Ablation Catheter is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat supraventricular tachycardia (e.g., macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia) in patients with congenital heart disease in whom vascular or target chamber access by conventional manual catheter navigation is limited due to underlying anatomic abnormalities and/or previous surgical interventions.

About Stereotaxis

Stereotaxis (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 .

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. Fischel

Chairman and Chief Executive Officer

Kimberly Peery

Chief Financial Officer

314-678-6100



EN
06/01/2026

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Stereotaxis

 PRESS RELEASE

Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter

Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter ST. LOUIS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter. “FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. It ensures the benefits of Robotic Magnetic Navigation can support patients with comple...

 PRESS RELEASE

Stereotaxis to Participate in Piper Sandler 37th Annual Healthcare Con...

Stereotaxis to Participate in Piper Sandler 37th Annual Healthcare Conference ST. LOUIS, Nov. 24, 2025 (GLOBE NEWSWIRE) -- (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that the company will participate in the . David Fischel, Stereotaxis Chairman and CEO, is scheduled to participate in a fireside discussion on Wednesday, December 3rd, 2025, at 9:00 am Eastern Standard Time and will be available that same day for one-on-one meetings. “This is an exciting period for Stereotaxis as we achieve key regulator...

 PRESS RELEASE

Stereotaxis Reports 2025 Third Quarter Financial Results

Stereotaxis Reports 2025 Third Quarter Financial Results ST. LOUIS, Nov. 11, 2025 (GLOBE NEWSWIRE) -- (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the third quarter ended September 30, 2025. “We continue to focus on driving commercial progress while advancing a robust portfolio of technologies through regulatory and development milestones,” said David Fischel, Chairman and CEO. “This is an exciting milestone-rich period in which we are demonstrating the tangible reality and initial...

 PRESS RELEASE

GenesisX Robotic Magnetic Navigation System Receives U.S. FDA Clearanc...

GenesisX Robotic Magnetic Navigation System Receives U.S. FDA Clearance ST. LOUIS, Nov. 10, 2025 (GLOBE NEWSWIRE) -- (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received U.S. Food and Drug Administration 510(k) clearance for its latest generation robotic system, . GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic Navigation while significantly enhancing the accessibility of the technology for healthcare providers. The sys...

 PRESS RELEASE

Stereotaxis to Report Third Quarter 2025 Financial Results on November...

Stereotaxis to Report Third Quarter 2025 Financial Results on November 11, 2025 ST. LOUIS, Oct. 21, 2025 (GLOBE NEWSWIRE) -- (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 third quarter on Tuesday, November 11, 2025 at the close of the U.S. financial markets. The Company will host a conference call and webcast at 4:30 p.m. ET that day to discuss the Company’s results and corporate developments. What:Stereotaxis third quarter 2025 financial results conferen...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch