Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter

Rhea-AI Summary

Stereotaxis (NYSE: STXS) announced FDA approval on January 6, 2026 of the MAGiC™ Magnetic Interventional Ablation Catheter for robotic cardiac electrophysiology procedures.

The MAGiC catheter is robotically navigated for mapping, diagnostic pacing, and creating endocardial lesions to treat supraventricular tachycardia in patients with congenital heart disease when conventional manual navigation is limited.

The company highlighted MAGiC's precision, expanded access for complex/underserved patients, and prior global use of Stereotaxis technology in over 150,000 patients.

Positive

• FDA approval of MAGiC on Jan 6, 2026
• Indicated for SVT treatment in congenital heart disease patients with limited access
• Stereotaxis technology used in over 150,000 patients

Negative

• No assurance company will recognize revenue from customer orders; orders may be delayed or canceled
• Commercial adoption and market acceptance of MAGiC are uncertain and could limit near-term sales

News Market Reaction

+8.05% 2.8x vol

20 alerts

+8.05% News Effect

+6.4% Peak in 1 hr 49 min

+$19M Valuation Impact

$258M Market Cap

2.8x Rel. Volume

On the day this news was published, STXS gained 8.05%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.4% during that session. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $19M to the company's valuation, bringing the market cap to $258M at that time. Trading volume was elevated at 2.8x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients treated: over 150,000 patients

1 metrics

Patients treated over 150,000 patients Cumulative patients treated with Stereotaxis technology worldwide

Market Reality Check

Price: $2.75 Vol: Volume 336,169 is slightl...

normal vol

$2.75 Last Close

Volume Volume 336,169 is slightly below the 20-day average of 389,797 ahead of the FDA news. normal

Technical Shares at $2.36 are trading slightly below the 200-day MA of $2.41 despite the approval.

Peers on Argus

STXS was up 1.72% pre-news while peers were mixed: OSUR +3.78%, STSS +11.5%, MBO...

STXS was up 1.72% pre-news while peers were mixed: OSUR +3.78%, STSS +11.5%, MBOT -0.95%, INFU +4.26%, NYXH +0.86%, suggesting a stock-specific catalyst rather than a uniform sector move.

Historical Context

5 past events · Latest: Nov 24 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 24	Conference participation	Positive	+1.7%	Participation in major healthcare conference and highlighting milestones.
Nov 11	Quarterly earnings	Neutral	+2.1%	Q3 2025 results and updates on regulatory and commercial progress.
Nov 10	FDA clearance	Positive	+2.6%	U.S. FDA 510(k) clearance for GenesisX robotic system.
Oct 21	Earnings announcement	Neutral	-1.6%	Scheduling of Q3 2025 earnings release and conference call.
Oct 15	Regulatory submission	Positive	+3.3%	EU launch and FDA 510(k) submission for Synchrony cath lab system.

Pattern Detected

Recent positive regulatory and product milestones, including prior FDA clearances, have generally coincided with modest positive price reactions.

Recent Company History

Over the past few months, Stereotaxis has reported several milestones, including FDA 510(k) clearance for GenesisX on Nov 10, 2025 and a CE Mark plus 510(k) submission for Synchrony on Oct 15, 2025. Q3 2025 results showed recurring revenue strength and highlighted early commercial sales of MAGiC and MAGiC Sweep. Conference participation in late November emphasized regulatory progress and early growth. The current MAGiC FDA approval extends this pattern of regulatory advancement in robotic electrophysiology solutions.

Market Pulse Summary

The stock moved +8.1% in the session following this news. A strong positive reaction aligns with a p...

Analysis

The stock moved +8.1% in the session following this news. A strong positive reaction aligns with a pattern where Stereotaxis has often seen gains following regulatory milestones such as prior FDA 510(k) clearances and CE Marks. However, historical moves have been relatively modest, so an outsized surge could reflect heightened expectations for MAGiC adoption. Investors evaluating sustainability may watch subsequent product uptake, reimbursement dynamics, and future regulatory updates, as well as the company’s ability to translate this approval into recurring procedure volume and revenue growth.

Key Terms

fda approval, robotic magnetic navigation, cardiac ablation, electrophysiology, +4 more

8 terms

fda approval regulatory

"today announced it obtained U.S. Food and Drug Administration (FDA) approval"

FDA approval is the U.S. Food and Drug Administration’s formal authorization for a drug, vaccine, or medical device to be marketed and sold after reviewers determine it meets standards for safety and effectiveness. For investors it’s a pivotal milestone because it opens the door to legal, large-scale sales and can sharply boost revenue potential while reducing regulatory uncertainty—like receiving a safety certificate that lets a new bridge carry traffic and tolls.

robotic magnetic navigation medical

"It ensures the benefits of Robotic Magnetic Navigation can support patients"

Robotic magnetic navigation is a medical system that uses external magnets and a robotic platform to steer a tiny magnetic-tipped catheter inside the body, most commonly during heart procedures to treat abnormal rhythms. For investors it matters because the technology can improve precision, safety and procedure speed, which affects clinical adoption, the value of expensive capital equipment and recurring disposable sales, and the regulatory and commercial risks tied to those revenue streams.

cardiac ablation medical

"represents a major advance in robotic cardiac ablation technology"

Cardiac ablation is a medical procedure that uses heat, cold, or energy to destroy small areas of heart tissue that cause abnormal electrical signals and irregular heartbeats. For investors, it matters because the procedure drives demand for specialized medical devices, hospital services, and ongoing treatment revenues, and changes in its safety, effectiveness, or insurance coverage can materially affect companies and clinical adoption—think of it as targeted surgery that resets a misfiring circuit in the heart.

electrophysiology medical

"pioneering robotics in electrophysiology. It ensures the benefits"

The study and measurement of the electrical signals that control cells and tissues, most commonly used to diagnose and treat heart rhythm problems and to test how nerves and muscles communicate. Investors care because electrophysiology drives products, procedures and drugs—like monitoring systems, catheter tools and implants—that can alter a medical device or drug maker’s sales, regulatory approvals and clinical trial outcomes; think of it as checking and fixing the wiring that makes the body run.

heart arrhythmia medical

"perform cardiac ablation procedures that treat heart arrhythmia."

An irregular heartbeat caused by the heart beating too fast, too slow, or unpredictably; it can range from harmless skipped beats to dangerous patterns that reduce blood flow. Investors should care because arrhythmias drive demand for drugs, medical devices, diagnostics, and hospital services, can affect clinical trial outcomes and regulatory reviews, and may create liability or cost risks for companies in healthcare and life sciences—think of it as a sudden glitch in a machine that can change repair and replacement markets.

endocardial lesions medical

"for the creation of endocardial lesions to treat supraventricular tachycardia"

Endocardial lesions are areas of damage or abnormal tissue on the endocardium, the heart’s inner lining that covers chambers and valves, caused by injury, infection, scarring, or interaction with implanted devices. They matter to investors because their detection, frequency, or prevention directly affects safety profiles, regulatory approval, clinical trial outcomes and potential liability for heart-related drugs or devices — like rust on a car that lowers resale value and raises repair costs.

supraventricular tachycardia medical

"lesions to treat supraventricular tachycardia (e.g., macroreentrant atrial tachycardia"

Supraventricular tachycardia (SVT) is a group of heart rhythm disorders where the heart suddenly beats much faster than normal because electrical signals above the heart’s ventricles fire too quickly. Think of it like a car engine revving uncontrollably for a short time; episodes can be brief or recurrent and may cause palpitations, dizziness or fainting. For investors, SVT matters because its prevalence, treatment options, and related devices or drugs influence demand, clinical trial outcomes, regulatory approvals, and healthcare costs.

congenital heart disease medical

"tachycardia) in patients with congenital heart disease in whom vascular"

A lifelong structural problem with the heart or its blood vessels that is present at birth, ranging from small defects to complex malformations; think of it as a plumbing or wiring fault in the heart that can affect how blood flows. It matters to investors because prevalence, treatment options, surgical procedures, medical devices, long-term care and drug development create predictable markets, cost pressures and regulatory pathways that influence healthcare company revenues and valuation.

AI-generated analysis. Not financial advice.

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

FAQ

What did Stereotaxis (STXS) announce on January 6, 2026?

Stereotaxis announced FDA approval of the MAGiC Magnetic Interventional Ablation Catheter for certain cardiac electrophysiology uses.

What clinical indication does the MAGiC catheter have under the FDA approval for STXS?

MAGiC is indicated for mapping, diagnostic pacing, and creating endocardial lesions to treat supraventricular tachycardia in congenital heart disease patients with limited manual access.

How might the MAGiC FDA approval affect Stereotaxis (STXS) commercial reach?

Approval may expand access to minimally invasive ablation in complex/underserved patients, but commercial uptake and timing remain uncertain.

Is MAGiC intended for all arrhythmia patients or specific cases for STXS?

MAGiC is indicated specifically for supraventricular tachycardia in patients with congenital heart disease where conventional navigation is limited.

Does the Stereotaxis press release guarantee revenue from MAGiC sales (STXS)?

No; the company stated there is no assurance it will recognize revenue from customer purchase orders, which may be contingent or canceled.

Where can investors find more information about Stereotaxis (STXS) products and regulatory status?

Investors can consult Stereotaxis investor relations and regulatory disclosures and the company's public filings for detailed information.