Da Vinci 5 Cleared for Cardiac Procedures

Rhea-AI Summary

Intuitive (NASDAQ: ISRG) announced FDA 510(k) clearance of the da Vinci 5 system for selected cardiac procedures on Jan. 26, 2026, expanding indications to include mitral valve repair and IMA mobilization for revascularization.

The release notes over 140,000 prior robotic cardiac procedures globally, a limited U.S. site rollout through 2026 to establish cardiac programs, and system capabilities including 10,000x computing power, instrumentation capturing 1,000+ data points/sec, advanced vessel/perfusion imaging, and an integrated digital ecosystem for planning through analytics.

Positive

• FDA 510(k) clearance expands da Vinci 5 cardiac indications effective Jan. 26, 2026
• System captures >1000 data points per second for advanced intraoperative data
• Integrated digital ecosystem supports pre-op planning through post-op analytics
• Limited U.S. site rollout in 2026 to establish initial cardiac programs

Negative

• Rollout limited to a small number of U.S. sites through 2026, slowing near-term adoption
• Cardiac indications use non-force feedback instruments, which may limit tactile sensing

News Market Reaction

+0.92%

1 alert

+0.92% News Effect

On the day this news was published, ISRG gained 0.92%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Annual CVD deaths: nearly 18 million Open heart surgeries: more than two million Robotic cardiac procedures: more than 140,000 +4 more

7 metrics

Annual CVD deaths nearly 18 million Global cardiovascular disease mortality mentioned as leading cause of death

Open heart surgeries more than two million Worldwide annual open heart surgery volume

Robotic cardiac procedures more than 140,000 Robotic-assisted cardiac procedures performed with da Vinci systems across 51 countries

Countries using da Vinci 51 countries Geographic reach of robotic-assisted cardiac procedures

Computing power 10,000x Da Vinci 5 computing power cited for future innovation and digital solutions

Data capture rate 1,000+ data points per second Smart instrumentation data capture capability

Innovation history 30 years Years of innovation Intuitive cites in support of cardiac initiative

Market Reality Check

Price: $525.04 Vol: Volume 2,716,321 is 1.54x...

high vol

$525.04 Last Close

Volume Volume 2,716,321 is 1.54x the 20-day average of 1,758,733, indicating elevated trading interest ahead of and around this clearance. high

Technical Shares at $523.99 trade above the 200-day MA of $515.66, yet remain 14.94% below the $616 52-week high.

Peers on Argus

ISRG slipped 0.35% while key peers like WST (-3.8%), BDX (-1.81%), and RMD (-0.9...

ISRG slipped 0.35% while key peers like WST (-3.8%), BDX (-1.81%), and RMD (-0.94%) also traded lower, but no peers appeared in momentum scans and there were no same-day peer headlines, pointing to stock-specific factors around the da Vinci 5 cardiac news rather than a coordinated sector rotation.

Historical Context

5 past events · Latest: Jan 14 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 14	Prelim FY25 earnings	Positive	-2.7%	Preliminary Q4 and FY2025 results showing double-digit revenue and procedure growth.
Dec 10	Product clearance	Positive	-1.5%	FDA clearance expanding da Vinci SP indications for several general surgery uses.
Oct 21	Q3 2025 earnings	Positive	+0.9%	Strong revenue and procedure growth with expanding da Vinci and Ion installed bases.
Oct 08	AI software clearance	Positive	+1.6%	FDA-cleared AI navigation and imaging upgrades for the Ion endoluminal system.
Oct 07	Portfolio company funding	Neutral	-1.9%	Jupiter Endovascular’s oversubscribed Series B and recent 510(k) for Vertex Catheter.

Pattern Detected

Recent positive product and earnings news has sometimes been met with mixed or negative one-day reactions.

Recent Company History

Over the past several months, Intuitive reported strong growth, with Q3 2025 revenue $2.51B and preliminary Q4 2025 revenue ~$2.87B, alongside robust procedure expansion and da Vinci 5 placements. It has also secured multiple FDA clearances, including expanded indications for da Vinci SP and AI-driven upgrades for the Ion system. Despite these advances, one-day price reactions have been inconsistent, with several positive announcements followed by modest share declines. Today’s da Vinci 5 cardiac clearance continues the theme of broadening indications for its platforms.

Market Pulse Summary

This announcement highlights FDA 510(k) clearance expanding da Vinci 5 indications into selected car...

Analysis

This announcement highlights FDA 510(k) clearance expanding da Vinci 5 indications into selected cardiac procedures, including mitral valve and structural heart interventions. It builds on prior clearances for other platforms and reinforces Intuitive’s strategy of broadening minimally invasive applications. Investors may track metrics such as cardiac procedure volumes, the number of sites adopting da Vinci 5 cardiac programs through 2026, and future clinical evidence supporting outcomes and training scalability in this new specialty area.

Key Terms

510(k) clearance, mitral valve repair, internal mammary artery, cardiac revascularization, +4 more

8 terms

510(k) clearance regulatory

"FDA 510(k) clearance expands da Vinci 5 indications to include certain cardiac"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

mitral valve repair medical

"cleared the da Vinci 5 system for certain cardiac procedures, including mitral valve repair"

Mitral valve repair is a medical procedure to fix the heart’s mitral valve so it opens and closes properly, like repairing a door hinge to stop leaks or allow a full swing. Investors pay attention because how often and how the repair is done affects demand for surgical and catheter devices, hospital and outpatient services, and reimbursement rules; better outcomes or new techniques can change procedure volumes, pricing and regulatory risk for healthcare companies.

internal mammary artery medical

"including mitral valve repair and IMA (internal mammary artery) mobilization for cardiac"

A blood vessel running along the inside of the chest wall that supplies the chest and breast area; surgeons commonly use it as a durable “spare hose” to reroute blood around blocked heart arteries during bypass surgery. Investors care because how and how often this vessel is used affects demand for cardiac surgical devices, clinical outcomes, hospital costs and reimbursement, and can influence regulatory decisions and adoption of new treatments and technologies.

cardiac revascularization medical

"IMA (internal mammary artery) mobilization for cardiac revascularization."

Cardiac revascularization is a set of medical procedures that restore blood flow to the heart when arteries are narrowed or blocked, either by opening the artery with a small tube or device or by creating a new route around the blockage through surgery. Investors care because demand, costs, safety and outcomes for these treatments drive sales and profits for medical device makers, hospitals and insurers, and influence regulatory and reimbursement decisions—think of it like unclogging a vital pipe for the body.

sternotomy medical

"with most procedures requiring a sternotomy, an approach that involves splitting the"

A sternotomy is a surgical cut through the breastbone to open the chest so surgeons can reach the heart and nearby organs; think of it like opening a book to access the pages inside. It matters to investors because the approach influences procedure risk, recovery time, hospital length of stay, device design and adoption, and ultimately costs and reimbursement—factors that affect revenue and liability for hospitals, device makers and insurers.

thoracoscopically-assisted medical

"indicated for the following selected thoracoscopically-assisted cardiac surgical procedures"

A thoracoscopically-assisted procedure is a surgical technique in which a small camera and instruments are inserted through tiny openings in the chest so the surgeon can see and work inside the chest without a large incision—think of doing repairs through a keyhole while watching a video feed. For investors, this matters because such minimally invasive approaches typically reduce hospital stays, complications and recovery time, affecting procedure volumes, device demand, treatment costs and reimbursement dynamics in the healthcare market.

patent foramen ovale medical

"Patent foramen ovale closure Atrial septal defect repair Left atrial appendage"

A patent foramen ovale (PFO) is a small, flap-like opening between the right and left upper chambers of the heart that failed to close after birth; think of it as a hidden door that can allow tiny amounts of blood to pass where they normally wouldn’t. For investors, PFO matters because it can lead to targeted medical procedures, devices, and drugs, influence clinical-trial outcomes and regulatory approvals, and affect healthcare spending and liability risks tied to cardiovascular treatment options.

atrial septal defect medical

"Patent foramen ovale closure Atrial septal defect repair Left atrial appendage"

Atrial septal defect is a hole in the wall that separates the two upper chambers of the heart, allowing blood to mix between them. Like a doorway that shouldn’t be there, it can make the heart work harder and lead to symptoms or the need for procedures. Investors care because the condition drives demand for diagnostic tests, devices, surgeries and therapies, affects healthcare costs and reimbursement trends, and can influence clinical trial and regulatory risk for related companies.

AI-generated analysis. Not financial advice.

FDA 510(k) clearance expands da Vinci 5 indications to include certain cardiac procedures

SUNNYVALE, Calif., Jan. 26, 2026 (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 5 system for certain cardiac procedures, including mitral valve repair and IMA (internal mammary artery) mobilization for cardiac revascularization. 
        
Cardiovascular disease remains the leading cause of death worldwide, claiming nearly 18 million lives each year.ⁱ More than two million patients worldwide undergo open heart surgery annuallyⁱⁱ, with most procedures requiring a sternotomy, an approach that involves splitting the breastbone to open the chest and access the heart.

“Opening the chest to perform surgical procedures can involve significant pain, high risk of complications, and long recovery times that can affect patients’ physical and psychological wellbeing,” said Intuitive chief executive officer Dave Rosa. “This clearance reflects our commitment to advancing minimally invasive cardiac surgery so more surgeons and care teams can pursue improved outcomes for their patients.”

Cardiac surgery was the first specialty cleared on the original da Vinci System in 2002. Since then, more than 140,000 robotic-assisted cardiac procedures have been performed using da Vinci systems across 51 countries. While early milestones demonstrated clinical potential, a combination of technical limitations of first‑generation platforms and the absence of a global training and support infrastructure led Intuitive to shift its primary focus away from cardiac surgery. Today, with those barriers addressed and a mature ecosystem in place, minimally invasive cardiac surgery is positioned for meaningful expansion with da Vinci 5.

The design of da Vinci 5 can support minimally invasive cardiac procedures by enabling surgeons to operate through small incisions without opening the breastbone. The system offers:

• 10,000x computing power for future innovation and digital solutions.
• Smart instrumentation capturing 1,000+ data points per second.
• Advanced imaging for enhanced visualization of vessels and perfusion.
• An integrated digital ecosystem supporting the complete journey from pre-operative planning through post-operative analytics.

“Da Vinci 5 marks the beginning of a global initiative to help transform cardiac care,” said Intuitive’s global vice president of cardiac Darla Hutton. “By combining 30 years of meaningful innovation, structured team-based training programs and a service model built on reliability and safety, we believe we can enable cardiac teams to adopt robotic-assisted surgery in a consistent, scalable and sustainable way.”

To support adoption of cardiac surgery with da Vinci 5, Intuitive has established a dedicated team focused on building infrastructure, including the development of bespoke training programs, clinical evidence generation, and cardiac-specific instruments and accessories. A limited number of U.S. sites will begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs.

Da Vinci 5 is now indicated for the following selected thoracoscopically-assisted cardiac surgical procedures using non-force feedback instruments:

• Mitral valve repair 
• IMA mobilization for cardiac revascularization
• Patent foramen ovale closure
• Atrial septal defect repair
• Left atrial appendage closure/occlusion
• Atrial myxoma excision
• Mitral valve replacement
• Tricuspid valve repair
• Epicardial pacing lead placement
  

About Intuitive

Intuitive (NASDAQ:ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic-assisted 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.

Forward-Looking Statements

This press release contains forward-looking statements which relate to expectations concerning matters that are not historical facts. Statements using words such as “estimates,” “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “can,” “could,” “should,” “would,” “targeted,” “potential,” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements are necessarily estimates reflecting the judgment of Intuitive’s management and involve a number of risks and uncertainties that could cause actual results or impacts on its operations, financial performance, and business position to differ materially from those suggested by the forward-looking statements.

These forward-looking statements include, but are not limited to, statements related to research and development of products and services, manufacturing of products, integration of products, obtaining of regulatory approvals, technical and other performance of products and services, and making products and services available to more patients and health care professionals.

These forward-looking statements should be considered in light of various important factors and involve known and unknown risks, uncertainties, and other factors, which may cause the actual results, performance, or achievements of Intuitive, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, among others, economic conditions in the geographic markets in which we operate, changes in governmental regulations, regulatory approval priorities, resources, and timelines, regulatory enforcement priorities, governmental investigations and civil litigation, and other factors discussed in Intuitive’s Annual Reports and other filings with relevant securities regulators.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release and which are based on current expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those risk factors identified under the heading “Risk Factors” in Intuitive’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by its other filings with the U.S. Securities and Exchange Commission. Intuitive’s actual results may differ materially and adversely from those expressed in any forward-looking statements, and it undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

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ⁱ World Health Organisation (2025), ‘Cardiovascular diseases’. Available at: https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1
ⁱⁱ National Heart, Lung and Blood Institute (2022). ‘Heart Surgery’. Available at: https://www.nhlbi.nih.gov/health/heart-surgery

Contact Information:

Media.inquiries@intusurg.com
+1 408-523-8181 ext. 6934681

FAQ

What cardiac procedures is da Vinci 5 cleared for under the Jan. 26, 2026 FDA 510(k) for ISRG?

Da Vinci 5 is indicated for selected thoracoscopically-assisted cardiac procedures including mitral valve repair, IMA mobilization for revascularization, atrial septal defect repair, left atrial appendage closure, and others.

How will the da Vinci 5 clearance affect ISRG clinical adoption timelines in the U.S.?

A limited number of U.S. sites will begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs, indicating a staged rollout.

What technological features of da Vinci 5 did Intuitive highlight in the Jan. 26, 2026 announcement?

Key features include 10,000x computing power, smart instruments capturing 1,000+ data points/sec, advanced vessel and perfusion imaging, and an integrated digital ecosystem.

Does the da Vinci 5 cardiac indication include force‑feedback instruments?

No; the listed cardiac procedures use non‑force feedback instruments according to the announcement.

How many robotic cardiac procedures have been performed historically with da Vinci systems?

More than 140,000 robotic-assisted cardiac procedures have been performed across 51 countries.