MedPath

Medtronic Plans FDA Submission for Hugo Surgical Robot, Eyes US Launch in FY2026

• Medtronic is preparing to submit its Hugo surgical robot system for FDA authorization by March 2024, targeting initial approval for urology indications.

• The company reports significant international growth for Hugo, with procedure volumes more than doubling year-over-year in existing markets.

• Medtronic's surgical robotics expansion comes amid evolving competition in the soft tissue robotics market, where Intuitive Surgical maintains leadership with its da Vinci system.

Medtronic is advancing toward a significant milestone in its robotics program, announcing plans to submit its Hugo surgical robot system for FDA authorization by the end of March. The medical technology giant is targeting a U.S. market launch in fiscal year 2026, marking a crucial step in its expansion into the surgical robotics space.
The initial FDA submission will focus on urology indications, building on the system's existing presence in international markets where it received CE mark approval in 2021. CEO Geoff Martha reported that the company has already completed enrollment in clinical trials for additional applications, including hernia and benign gynecology procedures.
"In international markets, utilization continues to increase, and we've more than doubled Hugo procedure volume year-over-year," Martha stated during an investor presentation. He emphasized that Hugo would serve as "a growth driver for our surgical business in fiscal '26, and a meaningful growth driver for Medtronic in the midterm."

Market Dynamics and Competition

The planned U.S. launch comes at a time of increasing competition in the soft tissue robotics market. While Medtronic aims to challenge the dominant position of Intuitive Surgical, industry analysts suggest that Intuitive's new da Vinci 5 system will likely maintain its market leadership. Johnson & Johnson and several specialized medtech firms are also vying for market share in this growing sector.

Financial Performance Context

The expansion of Medtronic's robotics portfolio comes against the backdrop of mixed financial results. In the third quarter of fiscal year 2025, the company's medical surgical division, which includes its robotics business, reported revenue of $2.07 billion, representing a slight decline of nearly 2% year-over-year. This was the only division within Medtronic to show a decrease in revenue.

Strategic Growth Initiatives

Beyond surgical robotics, Medtronic is seeing significant momentum in other key areas. The company's cardiac ablation solutions business is projected to reach $1 billion in fiscal year 2025, with Martha expressing confidence in achieving $2 billion in the near term, driven by the growth of their pulsed field ablation (PFA) portfolio.
Supply constraints that previously affected PFA product availability have largely been resolved, according to Martha, positioning the company for stronger performance in this segment. Additionally, Medtronic is optimistic about opportunities in renal denervation, where it is one of only two companies with FDA-approved products, and anticipates Medicare coverage within the next eight months.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Grants IND Clearance to Gameto's Novel IVF Treatment Fertilo, Paving Way for Phase 3 Trials

Gameto, a $73 million-backed biotech startup, has received FDA Investigational New Drug clearance for Fertilo, their innovative IVF treatment. This milestone enables the company to initiate Phase 3 clinical trials in the United States, marking a significant step toward potentially offering a more affordable and less invasive fertility treatment option.

Microbot Medical Submits FDA Application for LIBERTY Endovascular Robotic System

Microbot Medical has submitted a 510(k) application to the FDA for its LIBERTY Endovascular Robotic System, marking a key step toward commercialization.
The submission follows the successful completion of the ACCESS-PVI pivotal human clinical trial, evaluating LIBERTY's safety and efficacy in peripheral vascular interventions.

Medtronic's Simplera CGM and InPen Insulin Delivery System Receive FDA Clearance

Medtronic's Simplera CGM, a sensor requiring no fingersticks or scanning, has been cleared by the FDA, enhancing diabetes management.
The InPen integrated smart insulin pen system, now compatible with Simplera CGM, also received FDA clearance, streamlining insulin delivery.

Distalmotion's Dexter Surgical Robot Receives FDA Approval for Inguinal Hernia Repair

Distalmotion's Dexter surgical robot has received FDA de novo approval for adult inguinal hernia repair, marking its entry into the U.S. market.
Dexter is designed to integrate into existing surgical workflows, offering a modular, small-format system intended to enhance accessibility and simplicity in robotic surgery.

Medtronic's Affera System Receives FDA Approval for Atrial Fibrillation Treatment

Medtronic's Affera Mapping and Ablation System, integrating mapping, RF, and PFA technologies, has gained FDA approval for treating persistent atrial fibrillation.
The Affera system is the first focal PFA system approved in the U.S., potentially driving significant revenue growth for Medtronic's electrophysiology (EP) business.

Imricor Advances Towards Regulatory Approval in US and Europe for MRI-Guided Cardiac Ablation Technology

Imricor's FDA premarket approval review for its initial module was successfully completed ahead of schedule, marking a significant step toward US approval.
In Europe, the Vision-MR Ablation Catheter 2.0 is awaiting final certification after a positive audit, aligning with the stringent Medical Device Regulations (MDR).

EBR Systems' WiSE CRT System Advances Toward FDA Approval After Filing Review

EBR Systems' PMA application for the WiSE CRT System has cleared the initial FDA filing review, advancing to the substantive review phase.
The FDA's substantive review will assess the effectiveness and safety of the WiSE CRT System, the first leadless pacemaker for the heart’s left ventricle.

Leo Pharma's Delgocitinib Filing Accepted in the US, Expanding JAK Inhibitor Market

Leo Pharma's delgocitinib, a JAK inhibitor, has been accepted for filing in the US, marking a significant step towards entering the American market.
The drug has already received approval in Europe, positioning it as a key growth driver for the Danish dermatology company.

Medtronic Gains FDA Approvals for Percept and Inceptiv Systems

Medtronic's Percept system, a 'pacemaker for the brain,' received FDA approval for managing movement disorders like Parkinson's disease by sending electrical signals to modulate brain rhythms.
The Inceptiv spinal cord stimulator, designed for chronic pain treatment, secured FDA approval with its unique ability to automatically adjust therapy, enhancing pain relief and maintaining stimulation levels.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy