Stereotaxis Receives U.S. FDA Clearance for MAGiC Sweep Catheter

Rhea-AI Summary

Stereotaxis (NYSE:STXS), a pioneer in surgical robotics, has received FDA 510(k) clearance for its MAGiC Sweep™ catheter, the world's first robotically navigated high-density electrophysiology mapping catheter. The innovative device features 20 electrodes for detailed cardiac mapping and integrates with Stereotaxis' Robotic Systems.

The MAGiC Sweep catheter offers significant advantages including efficient high-density mapping, extended reach and precision, atraumatic design, and improved anatomical accuracy. This marks Stereotaxis' first FDA clearance for an interventional catheter in nearly 20 years and represents a crucial milestone in the company's comprehensive innovation strategy for advancing robotics in electrophysiology.

Positive

• First-ever FDA clearance for a robotically navigated high-density mapping catheter
• First FDA clearance for an interventional catheter in nearly 20 years
• Technology has been used to treat over 150,000 patients globally
• Enhanced efficiency and precision in cardiac mapping procedures
• Potential to improve patient outcomes through more accurate arrhythmia diagnosis

Negative

• Success depends on market acceptance and adoption by healthcare providers
• Faces competitive pressures in the medical device market
• Subject to ongoing regulatory compliance requirements

Insights

Medical Device Expert

Stereotaxis' first FDA-cleared mapping catheter in 20 years combines robotics with high-density mapping, addressing a critical clinical gap.

The FDA 510(k) clearance of the MAGiC Sweep catheter represents a significant technological breakthrough in the electrophysiology field. This is the world's first robotically navigated high-density mapping catheter, combining two critical technologies that previously existed separately. The 20-electrode design enables comprehensive electroanatomical mapping while maintaining the precision and safety benefits of robotic navigation.

High-density mapping has transformed electrophysiology by providing detailed cardiac electrical activity visualization, critical for identifying arrhythmia sources. Previous robotic systems were limited to point-by-point mapping, which Dr. Tung correctly identifies as a barrier to robotic navigation adoption. MAGiC Sweep addresses this limitation directly.

The catheter's atraumatic design offers a safety advantage over rigid alternatives. By avoiding tissue distension, it likely produces more anatomically accurate maps, potentially improving ablation targeting precision. This is particularly valuable for complex arrhythmias where precise substrate identification is challenging.

The integration with Stereotaxis' existing robotic systems creates a comprehensive workflow solution rather than just an isolated device improvement. The mention of future automated mapping algorithms suggests a pathway toward increased procedural standardization and efficiency.

From a regulatory perspective, this 510(k) clearance indicates the FDA recognizes substantial equivalence to existing devices while acknowledging the novel integration of robotics with high-density mapping. This milestone, their first interventional catheter clearance in nearly two decades, signals Stereotaxis' renewed commitment to expanding their interventional portfolio beyond robotic platforms alone.

Healthcare Financial Analyst

FDA clearance for MAGiC Sweep unlocks potential revenue growth through catheter sales and addresses a key adoption barrier for Stereotaxis' robotic systems.

The FDA clearance of MAGiC Sweep represents a pivotal business development for Stereotaxis after a lengthy product drought in their interventional catheter portfolio. This approval addresses a critical competitive disadvantage Stereotaxis has faced in the electrophysiology market.

High-density mapping catheters have become standard tools in modern EP labs, and Stereotaxis' inability to offer a compatible option has likely limited adoption of their robotic navigation systems. This new catheter eliminates that barrier, potentially accelerating platform adoption while creating a new recurring revenue stream through disposable catheter sales.

The interventional cardiology device market follows a classic "razor/razor blade" business model, where institutions invest in capital equipment (the robotic system) but generate recurring revenue through disposables (catheters). MAGiC Sweep should enhance this revenue dynamic for Stereotaxis.

CEO David Fischel's statement positions this as just the first of multiple planned robotically-steered interventional devices, indicating a broader portfolio expansion strategy. This suggests Stereotaxis aims to leverage their robotic platform across additional high-margin catheter products.

The validation from key opinion leaders like Dr. Cooper and Dr. Tung demonstrates clinical interest, which is essential for adoption in the physician-driven medical device market. However, successful commercialization will depend on training programs, reimbursement pathways, and competitive positioning against established high-density mapping systems from larger competitors.

ST. LOUIS, July 28, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking MAGiC Sweep™ catheter. MAGiC Sweep is the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter, representing a significant advancement in the technology available to diagnose and treat complex arrhythmia patients.

High density mapping has transformed the EP field, enhancing cardiac ablation procedures by enabling more efficient, detailed and precise identification of arrhythmia origin. The combination of high-density mapping with robotics is designed to offer multiple improvements:

• Efficient High-Density Mapping: Equipped with 20 electrodes, MAGiC Sweep facilitates rapid and detailed electroanatomical mapping of the heart chambers.
• Extended Reach & Precision: Seamless integration with Stereotaxis’ Robotic Systems enables precise navigation of the catheter to otherwise difficult to reach areas of the heart.
• Atraumatic Design: The catheter's design prioritizes patient safety with an atraumatic shaft.
• Anatomical Accuracy: The catheter supports more anatomically accurate maps by avoiding the distension caused by rigid catheters.
• Efficient Workflow: MAGiC Sweep enables improved robotic procedural workflow, particularly as Stereotaxis advances algorithms that support automated mapping with MAGiC Sweep.
  

"The development of the first ever robotically navigated high-density mapping catheter is a major milestone for the EP field," said Dr. Roderick Tung, Chief of Cardiology and Director of Cardiovascular Clinical Research at The University of Arizona College of Medicine - Phoenix. "Mapping with multi-electrode catheters has taught us so much in both mechanism and therapy for both atrial and ventricular arrhythmias. Remaining limited to only point-by-point mapping has held back the adoption of robotic navigation, as we have become accustomed to seeing human arrhythmias in exquisitely high resolution. We look forward to the positive impact we expect MAGiC Sweep to have on our patients and new possibilities in the field."

"The ability to combine high-density mapping with robotics is an exciting long-awaited milestone for the community of robotic electrophysiologists and the broader EP field," said Dr. Daniel Cooper, Professor of Medicine and Director of Electrophysiology Lab at Washington University. "By helping us efficiently create more accurate and detailed maps of complex arrhythmia, robotic high-density mapping with MAGiC Sweep supports our efforts to provide the most effective and safe ablation procedures for our patients."

"FDA clearance of MAGiC Sweep marks a pivotal moment for Stereotaxis as we advance a broad portfolio of differentiated robotically-navigated catheters. MAGiC Sweep is Stereotaxis’ first FDA clearance for an interventional catheter in nearly 20 years, but is only the first of multiple robotically-steered interventional devices being advanced as part of our comprehensive innovation strategy," said David Fischel, Stereotaxis Chairman and CEO. "This catheter reflects our commitment to significant innovations that advance robotics in electrophysiology and across endovascular 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, 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. Fischel
Chairman and Chief Executive Officer

Kimberly Peery
Chief Financial Officer

314-678-6100
Investors@Stereotaxis.com

FAQ

What is the significance of Stereotaxis (STXS) receiving FDA clearance for MAGiC Sweep?

The FDA clearance represents a major milestone as MAGiC Sweep is the world's first robotically navigated high-density EP mapping catheter, designed to improve the diagnosis and treatment of complex arrhythmias.

What are the key features of Stereotaxis MAGiC Sweep catheter?

The catheter features 20 electrodes for rapid electroanatomical mapping, precise robotic navigation, atraumatic design, and improved anatomical accuracy without cardiac distension.

How many patients has Stereotaxis technology treated globally?

Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere.

What is the market impact of MAGiC Sweep for Stereotaxis (STXS)?

This is Stereotaxis' first FDA clearance for an interventional catheter in nearly 20 years and represents a significant advancement in their product portfolio for robotic electrophysiology procedures.

How does MAGiC Sweep improve cardiac procedures?

MAGiC Sweep enables more efficient, detailed, and precise identification of arrhythmia origin through high-density mapping combined with robotic navigation capabilities.