Intuitive Announces Expanded Indications for da Vinci SP

Intuitive (NASDAQ: ISRG) announced that the U.S. Food and Drug Administration cleared the da Vinci Single Port (SP) surgical system on Dec 10, 2025 for use in inguinal hernia repair, cholecystectomy, and appendectomy.

Rhea-AI Summary

Intuitive (NASDAQ: ISRG) announced that the U.S. Food and Drug Administration cleared the da Vinci Single Port (SP) surgical system on Dec 10, 2025 for use in inguinal hernia repair, cholecystectomy, and appendectomy.

The clearances expand SP’s U.S. indications beyond existing approvals in urology, colorectal, thoracic, and transoral procedures and build on prior international approvals in Europe, Japan, and Korea. The company highlights a supporting evidence base of more than 500 peer-reviewed publications and describes SP as enabling single-incision or natural-orifice access with three multi-jointed instruments and an articulating 3DHD endoscope.

Positive

• FDA clearance for three new procedures on Dec 10, 2025
• Adds inguinal hernia, cholecystectomy, appendectomy indications
• Supported by more than 500 peer-reviewed publications
• Already approved in Europe, Japan, and Korea

Negative

• None.

Argus Dec 11 session

-1.54% close to close Open Argus

Details

News Market Reaction – ISRG

On Dec 11, the first trading day after this news, ISRG closed 1.54% below the previous close.

Data tracked by StockTitan Argus for the Dec 11 session.

Key Figures

Peer-reviewed publications: more than 500 Multi-jointed instruments: up to 3 instruments Endoscope: articulating 3DHD endoscope

Peer-reviewed publications

more than 500

Evidence base supporting da Vinci SP safety, efficacy, and outcomes

Multi-jointed instruments

up to 3 instruments

Number of instruments controlled through single SP entry point

Endoscope

articulating 3DHD endoscope

Visualization tool routed through single SP entry point

Historical Context

5 past events · Latest: Oct 21

5 events

1. Oct 21

   Quarterly earnings

   24h Move

   +0.9%

   Strong Q3 growth in revenue and procedures with expanding system installs.

2. Oct 08

   Product clearance

   24h Move

   +1.6%

   FDA-cleared AI navigation and imaging upgrade for the Ion system.

3. Oct 07

   Financing news

   24h Move

   -1.9%

   Jupiter Endovascular oversubscribed Series B tied to ISRG-related ecosystem.

4. Sep 12

   Product update

   24h Move

   -1.4%

   New real-time surgical insight software features for da Vinci 5 platform.

5. Sep 09

   Customer adoption

   24h Move

   -0.5%

   System-wide launch of da Vinci 5 across MemorialCare hospitals.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

u.s. food and drug administration, fda, inguinal hernia, cholecystectomy, +4 more

8 terms

u.s. food and drug administration regulatory

"the U.S. Food and Drug Administration (FDA) has cleared the da Vinci"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"the U.S. Food and Drug Administration (FDA) has cleared the da Vinci"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

inguinal hernia medical

"include inguinal hernia repair, cholecystectomy, and appendectomy"

An inguinal hernia is when tissue, often part of the intestine, pushes through a weak spot in the lower abdominal wall near the groin, producing a visible bulge and sometimes pain or discomfort. For investors, it matters because it drives demand for surgical repairs, medical devices and related drugs, and can affect healthcare costs, procedure volumes and regulatory or reimbursement decisions—much like a recurring leak that signals ongoing repair and equipment needs in a building.

cholecystectomy medical

"include inguinal hernia repair, cholecystectomy, and appendectomy"

Cholecystectomy is the surgical removal of the gallbladder, an organ that stores bile used for digestion; surgeons often remove it through a few small incisions using minimally invasive techniques. For investors, procedure volumes and trends matter because they drive revenue for hospitals, surgical device makers, imaging suppliers and insurers—similar to how demand for car repairs affects parts manufacturers and garages. Shifts in how often or how the surgery is done can signal changes in healthcare spending and technology adoption.

appendectomy medical

"include inguinal hernia repair, cholecystectomy, and appendectomy"

An appendectomy is a surgical operation that removes the appendix, a small pouch attached to the large intestine, usually performed when the appendix becomes inflamed or infected. For investors, it matters because such procedures affect healthcare costs, hospital and device company revenues, and short-term workforce availability—think of it like a planned repair that temporarily pulls a machine out of service and creates predictable medical spending and care demand.

robotic-assisted surgery technical

"the pioneer of robotic-assisted surgery, today announced that the U.S."

Robotic-assisted surgery uses a surgeon-controlled robotic system to perform or assist with operations, where the doctor operates instruments through small incisions while a machine translates their movements into precise actions. For investors, it matters because these systems change procedure costs, hospital purchasing and training needs, and recurring revenue from instruments and service contracts—similar to how a new industrial robot can reshape manufacturing costs and output.

endoscope medical

"instruments and an articulating 3DHD endoscope through one entry point"

A slender, often flexible instrument with a tiny camera and light at the tip used by doctors to look inside the body through natural openings or small cuts; think of it as a miniature inspection camera for human organs. For investors, endoscopes matter because they are core medical devices whose sales, technological upgrades, and regulatory approvals directly affect revenues and market position of healthcare equipment makers and hospitals' ability to perform minimally invasive procedures.

minimally invasive medical

"a global technology leader in minimally invasive care and the pioneer"

Medical procedures described as minimally invasive use small cuts, flexible tubes or tiny cameras to treat or diagnose problems with far less cutting than traditional surgery — like using a keyhole instead of tearing down a wall. Investors care because these approaches can shorten hospital stays, lower complication rates and change equipment and reimbursement needs, which can speed adoption and reshape market demand for devices, supplies and services.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

FDA clearance expands da Vinci SP indications to include inguinal hernia repair, cholecystectomy, and appendectomy

SUNNYVALE, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the da Vinci Single Port (SP) surgical system for use in inguinal hernia repair, cholecystectomy, and appendectomy procedures.

These clearances expand da Vinci SP’s capabilities and build on its existing U.S. clearances in urology, colorectal, thoracic and transoral procedures.

“Da Vinci SP was designed to give surgeons advanced capability through a single port, offering the precision and control needed in narrow or deep anatomical spaces,” said Iman Jeddi, PhD, Senior Vice President and General Manager, da Vinci Platforms and Product Operations at Intuitive. “This clearance is one part of our innovation pathway for SP. We continue to evolve the platform with new tools and capabilities that help teams pursue less invasive approaches and expand what’s possible with da Vinci SP.”

The da Vinci SP system enables surgeons to perform procedures through a single incision or natural orifice, offering enhanced visualization and precision. Its design supports access to anatomy by allowing surgeons to control up to three multi-jointed instruments and an articulating 3DHD endoscope through one entry point.

“Advancing da Vinci SP is part of our long-term commitment to helping improve the future of patient care — supporting approaches that are less invasive, reduce recovery time, lower the total cost of care, and create a better experience for patients as they return to their lives,” said Myriam Curet, MD, Executive Vice President and Chief Medical Officer at Intuitive. “As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care.”

A growing body of evidence, including more than 500 peer-reviewed publications, supports the safety, efficacy, and outcomes associated with the da Vinci SP system. SP is also approved for use in Europe, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.

About Intuitive

Intuitive (NASDAQ: ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic surgery. Our technologies include the da Vinci surgical system and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where disease is identified early and treated quickly, so that patients can get back to what matters most.

About da Vinci Surgical Systems

There are several models of the da Vinci surgical system. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery and offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels, and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
For more information, please visit the company’s website at www.intuitive.com.

Important Safety Information

For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, visit https://manuals.intuitivesurgical.com/market. For summary of the risks associated with surgery refer to www.intuitive.com/safety.

Media contact:
Megan Elliott
megan.elliott@intusurg.com
+1 408-523-8181 ext. 6934681

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What new indications did Intuitive (ISRG) receive for da Vinci SP on Dec 10, 2025?

The FDA cleared da Vinci SP for inguinal hernia repair, cholecystectomy, and appendectomy on Dec 10, 2025.

How do the new FDA clearances change da Vinci SP's U.S. approvals for ISRG?

They expand U.S. indications beyond urology, colorectal, thoracic, and transoral procedures to include three general surgery procedures.

What evidence does ISRG cite to support da Vinci SP safety and efficacy?

The company cites a growing body of evidence including more than 500 peer-reviewed publications supporting SP outcomes.

Is da Vinci SP already approved outside the U.S. before the Dec 10, 2025 clearance?

Yes; SP is approved for a range of procedures in Europe, Japan, and Korea.

What surgical capabilities does da Vinci SP provide for surgeons using ISRG systems?

SP enables single-incision or natural-orifice access with control of up to three multi-jointed instruments and an articulating 3DHD endoscope.