Medical Device Information
Intuitive Surgical, Inc. - Global Leader in Robotic-Assisted Minimally Invasive Surgery

Intuitive Surgical, Inc. - Global Leader in Robotic-Assisted Minimally Invasive Surgery

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Key Milestones (2025–2026):
   In Q1 2026, Intuitive reported revenue of $2.77 billion (up 23% YoY), with worldwide procedures growing 17% and 431 da Vinci systems placed including 232 da Vinci 5 systems. The da Vinci installed base reACHed 11,395 systems and Ion reached 1,041 systems. In early 2026, the company surpassed 20 million patients treated with da Vinci surgery globally. In April 2026, the da Vinci SP single-port system passive instruments and accessories received NMPA approval in China (registration no. 国械注进20262020149). In the first half of 2026, Intuitive began direct sales operations in Italy, Spain, and Portugal, transitioning from distributor relationships.

Company Profile (Updated April 2026)

Intuitive Surgical, Inc. (NASDAQ: ISRG) is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. Founded in 1995 and headquartered in Sunnyvale, California, USA, the company develops, manufactures, and markets products that enAble physicians and healthcare providers to enhance the quality of and access to minimally invasive care.

The company's flagship da Vinci Surgical System translates the surgeon's hand movements at a console into corresponding micro-movements of instruments positioned inside the patient through small incisions. The system provides surgeons with high-definition 3D vision, enhanced dexterity, greater precision, and ergonomic comfort. Intuitive also offers the Ion endoluminal system, which extends its commercial offerings beyond surgery into diagnostic endoluminal procedures enabling minimally invasive biopsies in the lung.

Development History:

- 1995: Incorporated in California

- 1999: Received first FDA clearance for the da Vinci Surgical System for general laparoscopic surgery

- 2000: IPO on NASDAQ

- 2003: FDA clearance for cardiac surgery

- 2005: FDA clearance for gynecologic surgery

- 2009: Launched da Vinci Si system

- 2014: Launched da Vinci Xi system, the fourth generation

- 2018: Launched da Vinci X system and Ion endoluminal system

- 2018: Launched da Vinci SP (Single Port) system

- 2024: Launched da Vinci 5, the next-generation multiport system with integrated insufflation and enhanced precision

- 2024: Approximately 95,500 Ion biopsy procedures performed, up from 53,800 in 2023

- 2025: Full-year revenue reached $10.1 billion (up 20.5% YoY)

- 2026: Surpassed 20 million patients treated with da Vinci surgery globally

- 2026.04: Single-port endoscopic surgical instrument control system passive instruments and accessories (da Vinci SP accessories) received NMPA approval in china (registration no. 国械注进20262020149), produced by Intuitive Surgical, Inc., USA

- 2026: Began direct sales operations in Italy, Spain, Portugal, Malta, San Marino, and associated territories

Core Mission: To enable doctors and hospitals to deliver better patient outcomes, improve patient and care team experiences, lower total cost to treat, and increase access to care through minimally invasive approaches.

Core Product Portfolio

da Vinci Surgical Systems

- da Vinci 5: Latest-generation multiport system launched in 2024; features integrated insufflation technology, enhanced precision, and improved ergonomics; nearly 90% of procedures used integrated insufflation in Q3 2025

- da Vinci Xi: Fourth-generation multiport system for complex procedures across multiple quadrants

- da Vinci X: Lower-cost multiport system with core Xi capabilities

- da Vinci SP: Single-port system enabling surgery through one incision; NMPA-approved accessories available in China (April 2026)

Ion Endoluminal System

- Ion: Robotic-assisted platform for minimally invasive lung biopsies; extends Intuitive's reach from surgery into diagnostic procedures

- Procedure Growth: Ion procedures grew approximately 39% in Q1 2026; installed base reached 1,041 systems

Instruments & Accessories

- EndoWrist Instruments: Articulating instruments that mimic human wrist movement

- Stapling and Energy: Advanced stapling and vessel sealing technologies

- Vision Systems: High-definition 3D vision and fluorescence imaging

- SP System Accessories: Passive instruments and accessories for the da Vinci SP single-port system; NMPA approved April 2026 (国械注进20262020149)

Services & Digital

- Intuitive Care: Installation, repair, maintenance, 24/7 technical support, and proactive system health monitoring

- MyIntuitive: Digital platform providing connected offerings, program-enhancing insights, and performance analytics for hospitals

- Learning Pathways: Progressive training and education programs for surgeons and care teams

Regulatory & Market Access

- United States (FDA): Multiple clearances for da Vinci systems (Si, Xi, X, SP, 5) and Ion; De Novo and 510(k) pathways

- China (NMPA): da Vinci SP system passive instruments and accessories approved April 2026 (国械注进20262020149); multiple da Vinci system registrations for Chinese market

- European Union: CE marking for da Vinci and Ion systems

- Japan: PMDA approvals for da Vinci systems

- Global Reach: 70+ countries with regulatory approvals

Financial Performance

Q1 2026 Results (Quarter Ended March 31, 2026)

Revenue: $2.77 billion (up 23% YoY from $2.25 billion in Q1 2025)

GAAP Net Income: $822 million, or $2.28 per diluted share (vs. $698 million, or $1.92 in Q1 2025)

Non-GAAP Net Income: $901 million, or $2.50 per diluted share (vs. $662 million, or $1.81 in Q1 2025)

da Vinci System Placements: 431 systems (vs. 367 in Q1 2025), including 232 da Vinci 5 systems (vs. 147 in Q1 2025)

Ion System Placements: 52 systems (vs. 49 in Q1 2025)

da Vinci Installed Base: 11,395 systems (up 12% from 10,189 in Q1 2025)

Ion Installed Base: 1,041 systems (up 22% from 853 in Q1 2025)

Worldwide Procedures: Grew approximately 17% (da Vinci 16%, Ion 39%)

Share Repurchases: 2.3 million shares for $1.1 billion

FY2025 Results (Year Ended December 31, 2025)

Revenue: $10.1 billion (up 20.5% YoY)

Operating Income: $2.95 billion (up 25.4% YoY); Operating Margin: 29.3%

Gross Profit: $6.6 billion; Gross Margin: 66.0% (down from 67.5% in 2024 due to tariffs and da Vinci 5 production costs)

Recurring Revenue: $7.04 billion (84% of total revenue), including instruments, accessories, service, and operating lease revenue

Cash and Investments: $9.10 billion (as of Q1 2025)

Q4 2025 Results

Revenue: $2.87 billion (up 18.8% YoY)

Adjusted EPS: $2.53 (vs. estimate of $2.26)

Company Overview

Corporate Information

Legal Name: Intuitive Surgical, Inc.

Founded: 1995

Headquarters: Sunnyvale, California, USA

Stock Exchange: NASDAQ

Stock Code: ISRG

Company Type: Public listed company

Industry: Medical Technology / Surgical Robotics / Minimally Invasive Care

Market Cap: Approximately $166 billion (as of early 2026)

Employees: ~13,000+

Website: www.intuitive.com

Leadership Team

Chief Executive Officer: Gary S. Guthart, PhD

- Joined Intuitive in 1996; became CEO in 2010; leads global strategy and innovation

Chief Financial Officer: Jamie E. Samath

- Oversees financial operations, investor relations, and strategic planning

Chief Executive Officer (CEO Title per SEC filings): David J. Rosa

- EVP and Chief Operating Officer; extensive operational leadership experience

EVP & Chief Medical Officer: Myriam Curet, MD

- Leads clinical strategy, medical affairs, and evidence generation

EVP & Chief Digital Officer: Brian Edward Miller

- Drives digital strategy, MyIntuitive platform, and connected care offerings

EVP & Chief Commercial and Marketing Officer: Henry L. Charlton

SVP & Chief Manufacturing and Supply Chain Officer: Mark Brosius

VP Corporate Controller: Fredrik Widman

Global Market Presence

Installed Base (As of Q1 2026)

- da Vinci Systems: 11,395 systems globally (up 12% YoY)

- Ion Systems: 1,041 systems globally (up 22% YoY)

- Geographic Reach: 70+ countries; direct sales in major markets including U.S., Japan, Germany, France, UK, and expanding direct operations in Italy, Spain, Portugal

- Patients Treated: Over 20 million patients globally

Procedure Volume

- da Vinci Procedures: Grew approximately 16% in Q1 2026

- Ion Procedures: Grew approximately 39% in Q1 2026

- Key Procedure Categories: General surgery, gynecologic surgery, urologic surgery, cardiothoracic surgery, head and neck surgery

Key Competitors

- Medtronic (Hugo RAS): Robotic-assisted surgery system

- Johnson & Johnson (Ottava): Developing robotic surgery platform

- Stryker (Mako): Orthopedic robotic surgery (different segment)

- CMR Surgical (Versius): Modular laparoscopic robotic system

- Asensus Surgical (Senhance): Digital laparoscopic platform

- Johnson & Johnson (Monarch): Robotic endoluminal platform (Ion competitor)

Competitive Advantages

- Market Leadership: Dominant global share in robotic-assisted surgery with over 11,000 da Vinci systems installed

- Recurring Revenue Model: 84% of revenue from recurring sources (instruments, accessories, service, leases)

- Ecosystem Integration: Comprehensive platform spanning hardware, instruments, services, training, and digital analytics

- Clinical Evidence: 20+ million patients treated; extensive peer-reviewed publications supporting safety and efficacy

- Innovation Pipeline: Continuous platform evolution from da Vinci Xi to da Vinci 5 to Ion and future technologies

- Surgeon Training Network: Global learning pathways and proctoring programs creating high switching costs

2026 Strategic Outlook

- da Vinci 5 Rollout: Continue scaling da Vinci 5 placements and utilization globally

- Ion Expansion: Accelerate Ion endoluminal system adoption for lung biopsy procedures

- Geographic Expansion: Complete transition to direct sales in Southern Europe (Italy, Spain, Portugal)

- China Market: Leverage NMPA approval of da Vinci SP accessories to expand single-port surgery capabilities in China

- Digital Transformation: Expand MyIntuitive platform and connected care offerings to improve hospital program performance

- Procedure Growth: Target continued double-digit procedure volume growth across general surgery, gynecology, urology, and thoracic applications

- Margin Recovery: Address tariff impacts and scale da Vinci 5 manufacturing to improve gross margins toward historical levels

Contact Information

Global Headquarters

Address: Sunnyvale, California, USA

Phone: +1 (408) 523-2100

Website: www.intuitive.com

Investor Relations

Phone: +1 (408) 523-2161

Email: investorrelations@intusurg.com

Investor Website: isrg.intuitive.com

Keywords: Intuitive Surgical, ISRG, da Vinci, da Vinci 5, da Vinci Xi, da Vinci X, da Vinci SP, Ion, robotic surgery, minimally invasive surgery, surgical robot, laparoscopic surgery, endoluminal, lung biopsy, Sunnyvale, California, Gary Guthart, Jamie Samath, David Rosa, Myriam Curet, NASDAQ, robotic-assisted surgery, EndoWrist, general surgery, gynecology, urology, cardiothoracic, NMPA, 国械注进20262020149, single port

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