Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

Rhea-AI Summary

Medtronic (NYSE: MDT) announced FDA clearance of the Stealth AXiS™ surgical system on Feb 13, 2026, a unified platform that integrates planning, navigation and robotics for spine surgery.

The system features LiveAlign™ segmental tracking for real-time anatomic motion visualization, a modular robotic design for staged deployment, and architecture intended to support future cranial and ENT applications pending 510(k) clearance.

Positive

• FDA clearance for spine surgery (Feb 13, 2026)
• LiveAlign real-time segmental tracking reduces need for repeated imaging
• Integrated platform combines planning, navigation and robotics in one system
• Modular design enables staged deployment across hospitals and ambulatory surgery centers

Negative

• Cranial and ENT applications are pending 510(k) clearance, not yet approved
• Initial U.S. clearance is limited to spine procedures, narrower scope at launch

Key Figures

Navigation & robotics history: more than 50 years

1 metrics

Navigation & robotics history more than 50 years Medtronic leadership in surgical navigation and robotics

Market Reality Check

Price: $99.49 Vol: Volume 9,328,943 is close...

normal vol

$99.49 Last Close

Volume Volume 9,328,943 is close to the 9,060,068 20-day average (relative volume 1.03x). normal

Technical Trading above 200-day MA at 93.32, about 5.13% below the 52-week high and 26.81% above the 52-week low.

Peers on Argus

MDT was down 0.2% while key peers were mixed: SYK up 0.07%, BSX up 0.96%, EW dow...

MDT was down 0.2% while key peers were mixed: SYK up 0.07%, BSX up 0.96%, EW down 3.59%, ZBH down 0.39%, PHG down 2.54%, indicating stock-specific rather than broad sector movement ahead of this clearance.

Previous Clinical trial,fda approval Reports

4 past events · Latest: Jan 12 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	FDA 510(k) clearance	Positive	-0.6%	FDA 510(k) clearance for MiniMed Go Smart MDI diabetes system.
Dec 03	Robotics FDA clearance	Positive	+0.0%	FDA clearance of Hugo robotic-assisted surgery system for urologic use.
Apr 25	Device FDA approval	Positive	-0.1%	FDA approval of OmniaSecure smallest-diameter defibrillation lead and study data.
Nov 20	Diabetes FDA clearance	Positive	-1.1%	FDA clearance of new InPen app enabling Smart MDI with Simplera CGM.

Pattern Detected

Recent FDA/clinical milestones often saw flat-to-negative next-day moves despite positive product news, with 3 of 4 events showing divergence.

Recent Company History

Over the past year, Medtronic reported several FDA and clinical milestones, including clearances for the MiniMed Go™ Smart MDI system on Jan 12, 2026, the Hugo™ robotic-assisted surgery system on Dec 3, 2025, the OmniaSecure™ defibrillation lead on Apr 25, 2025, and the InPen™ app with Simplera™ CGM on Nov 20, 2024. These events expanded capabilities across diabetes, robotics, and cardiac devices. Price reactions around these approvals were generally modest, suggesting the market often discounts such positive updates quickly.

Historical Comparison

-0.4% avg move · Past FDA/clinical updates (4 events) produced an average 24h move of -0.44%, indicating historically...

clinical trial,fda approval

-0.4%

Average Historical Move clinical trial,fda approval

Past FDA/clinical updates (4 events) produced an average 24h move of -0.44%, indicating historically modest, slightly negative reactions to similar regulatory milestones.

Recent same-tag events show Medtronic steadily expanding its FDA-cleared portfolio across diabetes (MiniMed Go, InPen app), robotics (Hugo RAS), and cardiac devices (OmniaSecure lead), with today’s Stealth AXiS™ spine system clearance extending that trajectory into integrated spine surgery platforms.

Market Pulse Summary

This announcement highlights FDA clearance of the Stealth AXiS™ system, an integrated planning, navi...

Analysis

This announcement highlights FDA clearance of the Stealth AXiS™ system, an integrated planning, navigation, and robotics platform for spine surgery built on over 50 years of Medtronic experience. In recent years, the company has secured multiple clearances across diabetes, robotics, and cardiac devices under the same clinical trial/FDA approval theme. Investors may track adoption of Stealth AXiS™, expansion into cranial and ENT indications, and how these launches contribute to growth versus past cleared platforms.

Key Terms

fda clearance, 510(k) clearance, ambulatory surgery centers, surgical navigation, +1 more

5 terms

fda clearance regulatory

"today announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

510(k) clearance regulatory

"future cranial and ENT applications, pending 510(k) clearance."

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

ambulatory surgery centers medical

"across hospitals and ambulatory surgery centers without relying on multiple"

Ambulatory surgery centers are medical facilities where patients undergo planned surgical or diagnostic procedures and leave the same day, without an overnight hospital stay. They matter to investors because they often deliver care more cheaply and efficiently than full hospitals, which can boost patient volume and profit margins; changes in insurance reimbursement, regulation, or patient preference can therefore directly affect revenue and growth potential.

surgical navigation technical

"more than 50 years of Medtronic leadership in surgical navigation and robotics"

A surgical navigation system is a real-time guidance tool surgeons use during procedures, like a GPS for the operating room that shows instruments and anatomy on a screen to improve placement and avoid critical structures. Investors care because these systems can raise procedure accuracy, reduce complications and operating time, and drive demand for compatible devices and software, which affects sales, reimbursement prospects, regulatory review and competitive positioning in medical markets.

robotics technical

"more than 50 years of Medtronic leadership in surgical navigation and robotics"

Robotics is the design, building and programming of machines that can perform physical tasks autonomously or with minimal human control, ranging from simple mechanical helpers to complex intelligent systems. For investors, robotics matters because these machines can boost productivity, cut operating costs, and create new markets much like adding a team of tireless, precise workers; companies that develop or adopt robotics can gain competitive advantages and shift future revenue and expenses.

AI-generated analysis. Not financial advice.

GALWAY, Ireland, Feb. 13, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system, a next-generation platform that brings planning, navigation, and robotics together into a single, intelligent system for spine surgery.

The Stealth AXiS™ system is cleared for spine procedures in the United States, with an underlying architecture designed to support future cranial and ENT applications, pending 510(k) clearance. Built to support a wide range of surgeon preferences, clinical complexity, and care settings, the platform is designed for use across hospitals and ambulatory surgery centers without relying on multiple standalone technologies.

Grounded in more than 50 years of Medtronic leadership in surgical navigation and robotics, the Stealth AXiS™ system creates a clear pathway for adoption by combining familiar navigation workflows with a modular robotic design, allowing institutions to deploy what they need today and expand over time as clinical needs evolve.

"The Stealth AXiS™ system represents a meaningful step forward in how we think about navigation and robotics working together," said Ronald A. Lehman, Jr., M.D., Tenured Professor of Orthopaedic Surgery (Neurological Surgery) at Columbia University, Division Chief of Spine Surgery, and Spine Medical Director at The Spine Hospital at NewYork-Presbyterian/The Allen Hospital, and a paid consultant to Medtronic. "One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure. The Stealth AXiS™ system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow. To me, this is truly game changing technology."

A key innovation of the Stealth AXiS™ system is LiveAlign™ segmental tracking, an industry-first capability that allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spine surgery, without the need for repeated imaging. This capability helps reduce reliance on manual steps and workflow disruption, supporting more consistent execution of patient-specific surgical plans.

As a cornerstone of Medtronic's AiBLE™ smart ecosystem, the Stealth AXiS™ system enables a more intuitive and seamless flow of information across the surgical continuum. By natively integrating planning, navigation, and execution within a single platform, the Stealth AXiS™ system helps streamline workflows and supports the exchange of insights before, during, and after spine surgery, allowing the broader AiBLE™ ecosystem to connect devices, software, and data in a more meaningful way.

"Spine surgery is complex, and variability remains a real challenge," said Michael Carter, Senior Vice President and President of Medtronic Cranial & Spinal Technologies. "The Stealth AXiS™ system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalized care while laying the foundation for continued innovation."

The Stealth AXiS™ surgical system reflects Medtronic's focus on building durable platforms that simplify surgical workflows today while enabling future expansion across procedures, specialties, and care settings.

For more information about the Stealth AXiS™ surgical system and the AiBLE™ smart ecosystem, visit www.Medtronic.com/StealthAxis.

About the Cranial & Spinal Technologies Business at Medtronic
As the global market leader, Medtronic Cranial and Spinal Technologies is transforming the standard of care in spine and cranial surgery by putting patients first and addressing the complex challenges faced by spine and neurosurgeons. With a portfolio of 150 products covering more than 20 pathologies, we serve over 4 million patients annually. Building on a legacy of innovation, our AiBLE™ ecosystem integrates advanced technologies, data, and AI with a patient-centric approach, offering customizable solutions to enhance surgical precision, improve workflow efficiency, and achieve better outcomes, before, during, and beyond surgery.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.

For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Christine Stewart
Public Relations
+1-269-377-2557

Ingrid Goldberg
Investor Relations
+1-763-505-2696

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SOURCE Medtronic plc

FAQ

What did Medtronic (MDT) announce on February 13, 2026 about the Stealth AXiS surgical system?

Medtronic announced FDA clearance of the Stealth AXiS system for spine surgery on Feb 13, 2026. According to the company, the platform integrates planning, navigation, and robotics and includes LiveAlign segmental tracking to visualize anatomic motion in real time without repeated imaging.

How does the Stealth AXiS LiveAlign feature benefit surgeons and patients for MDT?

LiveAlign provides real-time visualization of segmental spinal motion during procedures, reducing workflow interruptions. According to the company, this capability helps surgeons execute patient-specific plans more consistently and lowers reliance on repeated intraoperative imaging.

Is the Stealth AXiS surgical system from Medtronic (MDT) approved for cranial and ENT procedures?

No, cranial and ENT uses are not yet approved and are pending further regulatory clearance. According to the company, the system's architecture is designed to support future cranial and ENT applications, subject to additional 510(k) approvals.

What settings is the Medtronic Stealth AXiS system intended for and how does that affect deployment (MDT)?

The system is designed for use across hospitals and ambulatory surgery centers to support varied clinical settings. According to the company, a modular robotic design lets institutions deploy required capabilities now and expand functionality over time.

What is the strategic significance of Medtronic's (MDT) Stealth AXiS integration with the AiBLE ecosystem?

The Stealth AXiS integrates with Medtronic's AiBLE ecosystem to unify data, planning, and execution across the surgical continuum. According to the company, this native integration aims to streamline workflows and connect devices, software, and data before, during, and after surgery.