Is FDA Clearing da Vinci SP for General Surgery Altering The Investment Case For Intuitive Surgical (ISRG)?

• In December 2025, Intuitive Surgical received U.S. FDA clearance to use its da Vinci Single Port robotic system for inguinal hernia repair, cholecystectomy, and appendectomy, extending earlier approvals in urology, colorectal, thoracic, and transoral surgery.
• This expansion into high-volume general surgery, backed by extensive clinical evidence and existing approvals across the U.S., Europe, Japan, and Korea, could meaningfully deepen utilization of Intuitive’s SP platform.
• We’ll now examine how adding high-volume general surgeries to da Vinci SP’s label could influence Intuitive Surgical’s investment narrative and growth mix.

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Intuitive Surgical Investment Narrative Recap

To own Intuitive Surgical, you generally need to believe that robotic-assisted, minimally invasive surgery will keep gaining share across multiple specialties, driving higher procedure volumes and recurring revenue from an expanding installed base. The new U.S. FDA clearances for da Vinci SP in common general surgeries could support near-term procedure growth, but do not remove key risks like reimbursement pressure or competition, which remain the most important swing factors for the stock right now.

Among recent developments, the FDA approval of Medtronic’s Hugo system for U.S. urologic procedures is especially relevant, as it directly tests Intuitive’s pricing power and share in one of its core categories. As Intuitive looks to deepen da Vinci SP utilization in high-volume general surgery, how hospitals respond to new competing platforms could shape both system placements and the mix of higher margin consumables.

Yet even with these growth opportunities, investors should be aware of how increasing competition in robotic instruments and remanufactured consumables could...

Read the full narrative on Intuitive Surgical (it's free!)

Intuitive Surgical's narrative projects $13.4 billion revenue and $3.7 billion earnings by 2028. This requires 13.5% yearly revenue growth and about a $1.1 billion earnings increase from $2.6 billion today.

Uncover how Intuitive Surgical's forecasts yield a $596.36 fair value, a 8% upside to its current price.

Exploring Other Perspectives

Fifteen members of the Simply Wall St Community value Intuitive Surgical between US$325.55 and US$596.36 per share, underlining how far opinions can stretch. You might weigh those views against the risk that new rivals such as Medtronic’s Hugo system test Intuitive’s ability to defend high margin recurring revenue, which could have a meaningful influence on longer term performance.

Explore 15 other fair value estimates on Intuitive Surgical - why the stock might be worth as much as 8% more than the current price!

Build Your Own Intuitive Surgical Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Intuitive Surgical research is our analysis highlighting 2 key rewards that could impact your investment decision.
• Our free Intuitive Surgical research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Intuitive Surgical's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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