Short answer
Intuitive Surgical (ISRG) filed its fiscal 2025 10-K annual report with the SEC on Feb 3, 2026. It reported revenue of $10.1B (+20.5% year over year) and net income of $2.9B.
- Top risk flagged: UK medical device regulatory changes, new post-market rules effective June 16, 2025, with additional rules expected in 2026 potentially delaying UK market approval
FY2025 key financial metrics · XBRL
- Revenue
- $10.1B
- +20.5% YoY
- Net income
- $2.9B
- +23.0% YoY
- Operating margin
- 29.3%
- +1.1 pp YoY
- Gross margin
- 66.0%
- −1.5 pp YoY
- EPS (diluted)
- $7.87
- +22.6% YoY
- ROE
- 16.0%
- +1.9 pp YoY
- Operating cash flow
- $3.0B
- +25.5% YoY
Source: XBRL data from the Intuitive Surgical (ISRG) FY2025 10-K on SEC EDGAR. USD.
Intuitive Surgical FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: robotic-assisted minimally invasive surgical systems with integrated instruments, accessories, learning, and digital solutions
- New product emphasis: launched da Vinci 5 system with force feedback, 10,000x computing power of Xi, and My Intuitive+ digital subscription package
- Strategic shift: expanded digital ecosystem with My Intuitive app, SimNow VR simulator, Case Insights analytics, and Intuitive Hub edge computing
- Quantitative metric: da Vinci 5 features integrated electrosurgical unit, Integrated Table Motion; new 8mm SureForm 30 Curved-Tip stapler introduced
- Noteworthy fact: first commercial adoption of augmented reality 3D modeling service for pre-operative planning in kidney, prostate, lung, rectal procedures
Management Discussion & Analysis
- Tariffs increased cost of revenues by $63.0M in 2025; ongoing tariff impact expected to rise in 2026
- Installed base: 1,231 da Vinci 5 systems, 377 da Vinci SP systems as of Dec 31, 2025
- Numerous regulatory clearances in 2024-2026 including FDA approvals for da Vinci 5 multi-port & SP systems for expanded procedures
- Supply chain stress noted in Q4 2025 did not materially impact operations; elevated interest rates and tariff inflation are risks
- Expansion in China constrained by government quotas and provincial pricing limits; pricing pressure and procedural volume impact possible
Risk Factors
- UK medical device regulatory changes, new post-market rules effective June 16, 2025, with additional rules expected in 2026 potentially delaying UK market approval
- China anti-corruption campaign in healthcare since July 2023 causing tender cancellations, reducing system placements in 2025 versus expectations
- Tariffs on imports from Mexico (manufacturing base for majority of instruments) imposed in 2025 increasing product costs and reducing gross margins
- Competition from Medtronic plc and Johnson & Johnson focusing on robotic-assisted surgical systems and alternative therapies reducing market share
- Exposure to US Foreign Corrupt Practices Act, UK Bribery Act compliance risks in OUS operations with increasing business in China and complex local laws
Generated from the filing text; verify against the original. How to read a 10-K
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