Organization (Industry)
INTUITIVE SURGICAL, INC.
ClinicalTrials.gov lists INTUITIVE SURGICAL, INC. as lead sponsor of 62 trials. It has 1 active development program and 1 approved asset.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 5 registered with a 2026 start date. The hollow diamonds on the dashed line are a forecast of the full-year count, planned starts included: about 6 in 2026 and about 5 in 2027, the average of the 24 months through September, counted as registered and carried forward. The columns, the lighter one included, count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. This method has not been backtested on organizations. In backtests on conditions with as many trial starts a year as this organization (5 to 20), forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored. 1 trial is registered to start in 2027 or later.
Logo Intuitive Surgical, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers INTUITIVE SURGICAL, INC.: 62 lead-sponsored trials and 4 legal-entity registrations.
Disease areas (47)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Lung Neoplasms | 15 |
| Prostatic Neoplasms | 8 |
| Hernia, Inguinal | 6 |
| Colorectal Neoplasms | 5 |
| Hernia, Ventral | 5 |
Showing 5 of 47 disease areas.
Trials by start year as sponsor or collaborator (17)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 1 trial is registered to start in 2027 or later, and not listed here.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 5 |
| 2025 | 3 |
| 2024 | 7 |
| 2023 | 13 |
| 2022 | 10 |
| 2021 | 9 |
| 2020 | 12 |
| 2019 | 6 |
| 2018 | 6 |
| 2017 | 2 |
Showing 10 of 17 years.
Recruitment duration, a model prediction: 4 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (1)
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Administration of IS-002 | Prostatic Neoplasms | Phase 2 | 1 |
Approved assets (1)
| Drug | Trials |
|---|---|
| Indocyanine Green | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 57% hit target (n=37) | 31% on time (n=36) |
Journals published in (62)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Annals of surgery | 13 |
| Annals of surgical oncology | 9 |
| Surgical endoscopy | 6 |
| Journal of laparoendoscopic & advanced surgical techniques. Part A | 5 |
| Plastic and reconstructive surgery | 5 |
Showing 5 of 62 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 122 | 0 | 2010-05-18 |
SEC-reported annual financials (11)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 10,064,700,000 | 2,856,000,000 | 1,311,800,000 |
| 2024 | 8,352,100,000 | 2,322,600,000 | 1,145,300,000 |
| 2023 | 7,124,100,000 | 1,798,000,000 | 998,800,000 |
| 2022 | 6,222,200,000 | 1,322,300,000 | 879,000,000 |
| 2021 | 5,710,100,000 | 1,704,600,000 | 671,000,000 |
| 2020 | 4,358,400,000 | 1,060,600,000 | 595,100,000 |
| 2019 | 4,478,500,000 | 1,379,300,000 | 557,300,000 |
| 2018 | 3,724,200,000 | 1,127,900,000 | 418,100,000 |
| 2017 | 3,138,200,000 | 670,900,000 | 328,600,000 |
| 2016 | 2,706,500,000 | 738,300,000 | 239,600,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (6)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-04-30 | Other financing | not disclosed | Sec extracted |
| 2025-05-01 | Other financing | not disclosed | Sec extracted |
| 2025-01-21 | Other financing | not disclosed | Sec extracted |
| 2025-01-21 | Other financing | not disclosed | Sec extracted |
| 2022-10-24 | Other financing | not disclosed | Sec extracted |
Showing 5 of 6 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| OAI | 12 |
FDA recalls (257)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system | Class II | 2026-04-24 |
| Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Class II | 2026-04-22 |
| Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument | Class II | 2026-04-02 |
| Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 | Class I | 2026-03-11 |
| da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 | Class II | 2025-12-30 |
Showing 5 of 257 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 3 | 2020-02-07 |
Manufacturing and distribution sites (8)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| INTUITIVE SURGICAL, INC. | Sunnyvale, US | FDA | |
| INTUITIVE SURGICAL, INC. | Santa Clara, US | FDA | |
| INTUITIVE SURGICAL, INC. | Santa Clara, US | FDA | |
| INTUITIVE SURGICAL, INC. | SUNNYVALE, US | FDA | |
| INTUITIVE SURGICAL, INC. | Sunnyvale, US | FDA |
Showing 5 of 8 sites.
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | 45.0% |
Organization relationships (3)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Ruijin Hospital | Co sponsors trial with | 1 |
| Mayo Clinic | Co sponsors trial with | 1 |
| Siemens Corporation, Corporate Technology | Co sponsors trial with | 1 |
Latest dated events (490)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2027-01 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-08-28 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-07-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-05-20 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-05-14 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 490 events.
Biomarker capability evidence (10)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| BRCA1 | Trial collaborator | Named in trial inclusion criteria |
| INSM1 | Trial sponsor | Named in trial inclusion criteria |
| MATN1 | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
| LRP1 | Trial collaborator | Named in trial exclusion criteria |
Showing 5 of 10 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, fda warning letters, fda untitled letters, clia clinical laboratory certificates, and biomarkers this organization publishes on.