Intuitive Announces Expanded Indications for da Vinci SP

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.

Key Figures

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

Market Reality Check

$555.92 Last Close

Volume Volume 1,211,350 is below the 20-day average of 1,652,396, suggesting a muted reaction so far. normal

Technical Shares at 558.13 are trading above the 200-day MA of 508.41, while sitting 9.39% below the 52-week high.

Peers on Argus

ISRG fell 1.55% while key peers mostly declined modestly (e.g., BDX -0.57%, ALC -1.33%, RMD -1.48%, WST -0.96%), with HOLX fractionally higher, pointing to largely stock-specific dynamics rather than a strong sector-wide move.

Common Catalyst Only one peer (WST) reported news today, related to a quarterly dividend, with no clear shared catalyst around robotic or surgical platforms.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Oct 21	Quarterly earnings	Positive	+0.9%	Strong Q3 growth in revenue and procedures with expanding system installs.
Oct 08	Product clearance	Positive	+1.6%	FDA-cleared AI navigation and imaging upgrade for the Ion system.
Oct 07	Financing news	Positive	-1.9%	Jupiter Endovascular oversubscribed Series B tied to ISRG-related ecosystem.
Sep 12	Product update	Positive	-1.4%	New real-time surgical insight software features for da Vinci 5 platform.
Sep 09	Customer adoption	Positive	-0.5%	System-wide launch of da Vinci 5 across MemorialCare hospitals.

Pattern Detected

Recent news skewed positive on technology and growth, but price reactions have more often been negative or mixed, with 3 divergences versus 2 aligned moves.

Recent Company History

Over the last several months, Intuitive has reported strong fundamentals and steady platform innovation. Q3 2025 earnings on Oct 21 showed revenue of $2.51B, 23% year-over-year growth, and continued expansion of the da Vinci and Ion installed bases, with a modestly positive price reaction. Multiple product updates followed, including AI-driven navigation for the Ion system on Oct 8 and software enhancements for da Vinci 5 in September, which were met with small to moderate share price declines. Today’s FDA clearance for expanded da Vinci SP indications extends this pattern of incremental regulatory and platform advances.

Market Pulse Summary

This announcement extends the da Vinci SP platform into inguinal hernia repair, cholecystectomy, and appendectomy, adding to existing clearances in urology and other areas. It underscores Intuitive’s strategy of deepening minimally invasive options through a single-port system that controls up to three instruments and an articulating 3DHD endoscope. With more than 500 peer-reviewed publications supporting SP’s safety and efficacy, key factors to watch include adoption of these new indications, utilization trends, and continued software and tool innovation across the company’s platforms.

Key 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.

AI-generated analysis. Not financial advice.

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

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.