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Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter

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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

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AI Summary

Stereotaxis (STXS) has secured FDA approval for its MAGiC Magnetic Interventional Ablation Catheter, an innovation aimed at enhancing cardiac ablation precision and expanding access to therapy for complex arrhythmias. This approval is a pivotal milestone in robotic cardiac technology, emphasizing the company's commitment to improving patient outcomes within underserved populations.

Trading Thesis

STXS is poised for growth following FDA approval, signaling strong market potential.

Market-Moving

  • FDA approval increases STXS's credibility in the surgical robotics market.
  • Potential expansion of STXS’s market share in electrophysiology.
  • Enhanced investor interest expected due to significant product milestone.
  • Positive clinical outcomes anticipated may boost product adoption rates.
  • Competitive edge in robotic technology strengthens STXS's position.

Key Facts

  • FDA approved the MAGiC catheter on January 6, 2026.
  • Stereotaxis specializes in surgical robotics for minimally invasive interventions.
  • The MAGiC catheter is designed for cardiac electrophysiological procedures.
  • Over 150,000 patients have been treated globally with Stereotaxis technology.
  • The MAGiC catheter targets patients with complex congenital heart conditions.

Companies Mentioned

  • Stereotaxis (STXS): The approval of MAGiC positions STXS for significant market growth.
  • Banner University of Arizona Medical Center: Clinical support reinforces the catheter’s anticipated clinical efficacy.
  • Texas Cardiac Arrhythmia Institute: Potential adoption of MAGiC could drive usage in critical care settings.

Corporate Developments

This development falls under 'Corporate Developments,' showcasing STXS's innovation trajectory and fulfilling regulatory requirements. The approval significantly enhances the credibility and marketability of their robotic systems in a rapidly evolving healthcare sector.

FAQ

Why Very Bullish?

The FDA approval acts as a catalyst for STXS's growth, similar to past market responses seen with other medical innovations that received regulatory backing, suggesting potential price rises.

How important is it?

The FDA approval significantly elevates STXS's financial outlook, aligning with investor interests in innovative medical technologies, thus warranting a high importance score due to its potential to drive both revenue and brand trust.

Why Short Term?

The immediate market response should be favorable, driven by investor sentiment and clinical community advocacy, as observed in similar medical technology approvals.

Related Companies

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 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. Fischel

Chairman and Chief Executive Officer

Kimberly Peery

Chief Financial Officer

314-678-6100

Investors@Stereotaxis.com



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