Sentences and paragraphs of ISRG's Risk Factors and MD&A, 10-K 2026-02-03 against 10-K 2025-01-31.
Each links to the text at sec.gov.
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AddedRisk Factors
If a prolonged government shutdown occurs, or if funding shortages, staffing limitations, or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events could significantly impact the ability of the FDA, other regulatory authorities, or notified bodies to timely review and process our regulatory submissions, which may have an adverse effect on our business, financial condition or results of operations.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedRisk Factors
In the EU, subject to the transitional provisions and in order to sell our products in EU member states, our products must comply with the general safety and performance requirements of the EU MDR, which repeals and replaces the MDD. Compliance with these requirements is a prerequisite to be able to affix the CE mark to our products, without which they cannot be sold or marketed in the EU.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedRisk Factors
In addition, once our devices are certified under the EU MDR, we must inform the notified body that carried out the conformity assessment of the medical devices that we market or sell in the EU and the EEA of any planned substantial changes to our quality system or substantial changes to our medical devices that could affect compliance with the general safety and performance requirements laid down in Annex I to the EU MDR or cause a substantial change to the intended use for which the device has been CE marked. The notified body will then assess the planned changes and verify whether they affect the products’ ongoing conformity with the EU MDR. If the assessment is favorable, the notified body will issue a new certificate of conformity or an addendum to the existing certificate attesting compliance with the general safety and performance requirements and quality system requirements laid down in the Annexes to the EU MDR. The notified body may disagree with our proposed changes and product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedRisk Factors
If we fail to comply with applicable laws and regulations, we would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU. The aforementioned EU rules are generally applicable in the EEA. Non-compliance with the above requirements would also prevent us from selling our products in these three countries.
Read it in 10-K 2026-02-03 at sec.gov ↗
RemovedRisk Factors
•the building and maintenance of an organization capable of supporting geographically dispersed operations, including appropriate business procedures and controls;
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
In Israel, we have certain research and development operations primarily related to digital products. Depending on the length and extent of conflicts in the Middle East, including Israel and Iran, there may be adverse impacts to certain research and development timelines.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
In the UK, following a national referendum and enactment of legislation by the government, the UK formally withdrew from the EU and ratified a trade and cooperation agreement governing its relationship with the EU. The EU–UK Trade and Cooperation Agreement (the “TCA”) was applied provisionally as of January 1, 2021, and entered into force on May 1, 2021. The TCA does not specifically refer to medical devices. However, as a result of Brexit, the EU Medical Devices Regulation will not be implemented in the UK, and previous legislation that sought to mirror the EU Medical Devices Regulation in the UK law has been revoked. The regulatory regime for medical devices in Great Britain continues to be based on the requirements derived from previous EU legislation, and the UK may choose to retain regulatory flexibility or align with the EU Medical Devices Regulation going forward. On January 9, 2024, the MHRA published a roadmap setting out its plans and timelines towards the reform of the regulatory framework for medical devices in the UK. Regulations implementing core elements of the new framework are intended to be in place by 2025.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
Pending such reform of the UK regulatory framework, the Government has confirmed that general medical devices compliant with the EU Medical Devices Directive with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or June 30, 2028. Medical devices, including custom-made devices, compliant with the EU Medical Devices Regulation can be placed on the Great Britain market up until June 30, 2030. The rules for placing medical devices on the market in Northern Ireland, which is part of the UK, differ from those in Great Britain (England, Scotland and Wales) and continue to be based on EU law. The TCA does provide for cooperation and exchange of information in the area of product safety and compliance, including market surveillance, enforcement activities and measures, standardization-related activities, exchanges of officials, and coordinated product recalls (or other similar actions). For medical devices that are locally manufactured but use components from other countries, the “rules of origin” criteria will need to be reviewed. Depending on which countries products will ultimately be sold in, manufacturers may start seeking alternative sources for components if this would allow them to benefit from no tariffs. The rules for placing medical devices on the Northern Ireland market will differ from those in Great Britain. These developments, or the perception that any related developments could occur, have had and may continue to have a material adverse effect on global economic conditions and financial markets, and our business would likely be impacted and the demand for our products could be depressed.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
Moreover, if we fail to attract, motivate, or retain personnel or if we relax our standards in order to meet the demands of our growth, our corporate culture, our ability to achieve our strategic objectives, and our compliance with obligations under our internal controls and other requirements may be harmed. We believe that a critical contributor to our success has been our corporate culture, which we believe fosters innovation, teamwork, and a focus on execution, as well as facilitates critical knowledge transfer and knowledge sharing. We could also be subject to union or council efforts to organize our employees. These organizational efforts, if successful, decrease operational flexibility and could adversely affect our operating efficiency. In addition, our response to any organizational efforts could be perceived negatively and harm our business and reputation.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
obligations may be interpreted in ways that require us to modify our business practices and products to maintain compliance, potentially increasing costs and operational complexity.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
We are actively monitoring the situation in Ukraine and Russia and the conflict between Israel and Hamas and assessing the impacts on our business, including our business partners and customers. To date, we have not experienced any material interruptions in our infrastructure, supplies, technology systems, or networks needed to support our operations. We cannot predict the progress, outcome, or consequences of the military conflicts in Ukraine and the Israel-Gaza regions or their impacts on the global economy.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
In the U.S., an executive order was issued in October 2023 on the Safe, Secure and Trustworthy Development and Use of AI, emphasizing the need for transparency, accountability, and fairness in the development and use of AI, including in the healthcare industry. The order seeks to balance fostering innovation with addressing risks associated with AI by providing eight guiding principles and priorities, such as ensuring that consumers are protected from fraud, discrimination, and privacy risks related to AI. The order also calls for future regulations from various agencies, such as the Department of Commerce (to draft guidance for detecting and authenticating AI content) and the Federal Trade Commission (to ensure fair competition and reduce consumer harm). In alignment with the order, other agencies have published guidance. Agencies such as the Department of Commerce and the Federal Trade Commission have also issued proposed rules governing the use and development of AI technologies. Further, legislation related to AI technologies has been introduced at the federal level and is advancing at the state level. For example, on March 13, 2024, Utah passed the Utah AI Policy Act, which took effect in May 2024, imposing certain disclosure requirements on the use of AI and, on May 17, 2024, Colorado enacted the Colorado AI Act, which will take effect in February 2026. Further, the California Privacy Protection Agency is currently in the process of finalizing regulations under the CCPA regarding the use of automated decision-making. Such additional regulations may impact our ability to develop, use, and commercialize AI technologies in the future.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
Other jurisdictions where we operate have already or are also expected to introduce guidelines and regulations around the use of AI within the next few years. The regulations may impose onerous obligations and may require us to rework or reevaluate improvements to be compliant, potentially increasing costs.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
WE MAY INCUR LOSSES ASSOCIATED WITH CURRENCY FLUCTUATIONS AND MAY NOT BE ABLE TO EFFECTIVELY HEDGE OUR EXPOSURE.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
Our operating results are subject to volatility due to fluctuations in foreign currency exchange rates. Our primary exposure to fluctuations in foreign currency exchange rates relates to revenue and operating expenses denominated in currencies other than the U.S. dollar. The weakening of foreign currencies relative to the U.S. dollar adversely affects our foreign currency-denominated revenue. Gross profit margins on foreign currency-denominated revenue could also be materially adversely affected by foreign currency exchange rate fluctuations, as we may not be able to raise local prices to fully offset the strengthening of the U.S. dollar. Conversely, the strengthening of foreign currencies relative to the U.S. dollar, while generally beneficial to our foreign currency-denominated revenue and earnings, may cause us to reduce pricing on our products in
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedRisk Factors
markets that are not priced in U.S. dollars and may cause us to incur losses on our foreign currency hedging instruments, thereby limiting the benefit that strengthened foreign currencies could have on our results of operations.
Read it in 10-K 2025-01-31 at sec.gov ↗
RewordedRisk Factors
While we do not believe that we have experienced any significant system failure, accident, While, to date, no cyberattacks or security breach to date, breaches and incidents have had a material impact on our operations or financial results, if such an event were to occur, it could impair our ability to attract and retain customers for our products, customers, impact the price of our stock, materially damage commercial relationships, and expose us to litigation or government investigations, which could result in penalties, fines, or judgments against us.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
In the United States, the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and regulations implemented thereunder, or HIPAA, U.S., HIPAA imposes privacy, security, and breach notification obligations on covered entities and their business associates to ensure the confidentiality, integrity, and availability of individually identifiable health information.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
For example, during 2022, 2025, the adjusted closing price of our common stock reached a high of $360.00 $610.45 and a low of $183.06; during 2023, it reached a high of $354.93 and a low of $224.75; and, during 2024, it reached a high of $550.62 and a low of $322.13. $429.59.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
OUR BUSINESS IS SUBJECT TO COMPLEX AND EVOLVING LAWS AND REGULATIONS REGARDING DATA PRIVACY, DATA PROTECTION, ARTIFICIAL INTELLIGENCE, AND RESPONSIBLE USE OF DATA. DATA, AND ANY FAILURE TO COMPLY MAY RESULT IN SIGNIFICANT LIABILITY, NEGATIVE PUBLICITY, AND/OR EROSION OF TRUST, WHICH MAY ADVERSELY AFFECT OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
Our distributors may affect our ability to effectively market our products in certain countries or regulatory jurisdictions if a distributor holds the regulatory authorization or certification in such countries or within such regions and causes, by action or inaction, the suspension of such marketing authorization or certification or sanctions for non-compliance.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
In addition, in 2020, a new U.S. This regulation seeks was then expanded to prohibit companies contracting with the U.S. government from contracting with companies who use using the products or services of certain Chinese companies. companies anywhere in their operations.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business or results of operations, including the imposition of significant civil, criminal, and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in Medicare, Medicaid, other U.S. federal healthcare programs, or healthcare programs in other jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
DISRUPTIONS AT THE FDA AND OTHER GOVERNMENT AGENCIES OR NOTIFIED BODIES COULD HINDER THEIR ABILITY TO HIRE, RETAIN, OR DEPLOY PERSONNEL, OR OTHERWISE PREVENT OUR PRODUCTS FROM BEING DEVELOPED, CLEARED, CERTIFIED, APPROVED, OR COMMERCIALIZED IN A TIMELY MANNER OR AT ALL, OR COULD HINDER THEIR ABILITY TO PROCURE OUR PRODUCTS, WHICH MAY ADVERSELY AFFECT OUR BUSINESS, FINANCIAL CONDITION, OR RESULTS OF OPERATIONS.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
These changes included an aggregate reduction in Medicare payments, which went into effect on April 1, 2013, and will remain in effect through 2032, unless additional Congressional action is taken, with the exception of a temporary suspension due to the COVID-19 pandemic from May 1, 2020, through March 31, 2022. taken.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
Failure to submit required information at the designated times may result in civil monetary penalties for all payments, transfers of value, or ownership or investment interests not reported in an annual submission.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
Such tariffs and, if enacted, any further legislation or actions taken by the U.S. federal government that restrict trade, such as additional tariffs, trade barriers, and other protectionist or retaliatory measures taken by governments in Europe, Asia, and other countries, including reciprocal tariffs, limitations on government procurement, or technology export restrictions, could adversely impact our global operations and our ability to sell products and services in our OUS markets.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedRisk Factors
The systems of these external vendors may contain defects in design or manufacture or other problems that could unexpectedly compromise the security of our own information technology systems, systems and information, and we are dependent on these third parties to deploy appropriate security programs to protect their systems.
Read it in 10-K 2026-02-03 at sec.gov ↗
Quiet changesRisk Factors
The da Vinci surgical systems, Ion endoluminal system, and many of our other products represent a novel and advanced approach to performing medical procedures.
Read it in 10-K 2026-02-03 at sec.gov ↗
Quiet changesRisk Factors
Our operating results in any particular period will may not be a reliable indication of our future performance.
Read it in 10-K 2026-02-03 at sec.gov ↗
Quiet changesRisk Factors
It is possible that, in future periods, our operating results will could be below the expectations of securities analysts or investors.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
The following management's discussion and analysis should be read in conjunction with our Consolidated Financial Statements and Notes thereto.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
We refer to our fiscal years ended December 31, 2025, 2024, and 2023 as “2025,” “2024,” and “2023,” respectively. Unless the context requires otherwise, we are referring to Intuitive Surgical, Inc. and its consolidated subsidiaries when we use the terms “Intuitive,” the “Company,” “we,” “our,” or “us.”
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
Beginning in 2025, the U.S. implemented a baseline tariff framework on most imports with higher country- and product-specific rates for certain trading partners, including Mexico, Germany, and China, among others, alongside reciprocal measures announced by other jurisdictions. Our disclosure reflects tariffs currently in effect or announced as of the date of this report and assumes such tariffs remain in place, consistent with how we reflect tariff impacts in our financial outlook. We currently manufacture a significant majority of our instruments and accessories in Mexicali, Mexico. Most of these products qualify as originating under the USMCA and, therefore, have not been subject to U.S. import tariffs to date. We also import certain raw materials and finished goods from outside of the U.S. that are subject to tariffs, including our endoscopes, a majority of which are manufactured in Germany. In addition, our operations involve importing certain raw materials from China, importing sub-assemblies to support our local da Vinci Xi surgical system manufacturing in China, and selling U.S.-manufactured da Vinci Xi
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
surgical systems into China. These imports into the U.S. and China are subject to tariffs, which we expect to continue to have an adverse impact on the product cost of our da Vinci Xi surgical system in China.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
Some of our suppliers have also incurred incremental tariffs and have passed or may pass on those additional costs to us. These pass-through tariffs and other specific tariff actions against steel and aluminum, critical minerals, semiconductors, and other products have not had a material direct impact on our operations to date, but the long-term effect of these and other existing and future tariff actions is difficult to predict.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
U.S. tariffs have also given rise to trade measures by other countries, including additional restrictions on certain exports. These trade measures could impact the reliability and efficiency of our supply chain if they are imposed on materials important to our production operations. In particular, restrictions on the export of rare earth elements, including magnets, and critical minerals from China could potentially restrict access to components used in many of our products and could have a material adverse effect on our business, financial condition, or results of operations.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
In 2025, tariffs and other trade measures have increased our cost of revenues by approximately $63.0 million. Based on the announced and implemented global tariffs as of the date of this report, and assuming such tariffs remain in place, we expect our cost of revenues driven by tariffs and other trade measures to continue to increase in 2026. Future changes to tariff rates and the imposition of new tariffs by the U.S. and/or other countries could result in a material impact to our results of operations. The ultimate impact of changes to tariffs and trade barriers will depend on various factors, including the timing, amount, scope, and nature of any tariffs or trade barriers that are implemented, all of which could have a material adverse effect on our business, financial condition, or results of operations.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
Third parties have offered, and may continue to offer, instruments that have been modified to support the use of some of our limited-use instruments beyond their labeled life. We are aware that the FDA has granted 510(k) clearance for the remanufacturing of certain of these instruments for use with our da Vinci Si, da Vinci X, and da Vinci Xi surgical systems. To date, such offerings have not had a material impact on our revenues, but such activities could result in reduced revenue if these products have broader uptake as well as generate negative publicity for us if these products cause injuries and/or do not function as intended when used. Both of these possibilities could have a material adverse effect on our business, financial condition, or results of operations.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
For further details on remanufactured instruments, refer to the “Products & Services – Da Vinci – Instruments” section of our corporate website. The inclusion of a reference to our corporate website in this filing does not include or incorporate by reference the information on our website into this Form 10-K.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
During the fourth quarter of 2025, we continued to experience isolated stresses to supply, particularly for specific component materials impacted by evolving trade requirements and at certain subcontract suppliers that were operationally challenged to meet our production requirements. These isolated instances did not have a material impact on our business during the fourth quarter of 2025. As a result of the escalation in tariffs and country-specific trade requirements, including export license controls between major economies, we may experience tariff-related inflation in raw materials costs as well as supply shortages based on shipment delays and the availability of alternative sources of supply for critical materials used in the manufacture of finished products.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
•In January 2026, we obtained FDA clearance for the use of our da Vinci 5 surgical system in selected thoracoscopically-assisted cardiac surgical procedures using non-force feedback instruments, including mitral valve repair and replacement, tricuspid valve repair, IMA mobilization for cardiac revascularization, patent foramen ovale closure, atrial septal defect repair, left atrial appendage closure/occlusion, atrial myxoma excision, and epicardial pacing lead placement procedures.
Read it in 10-K 2026-02-03 at sec.gov ↗
AddedMD&A
•In September 2025, we obtained regulatory clearance in Japan for our Vessel Sealer Curved for use with our da Vinci 5, da Vinci X, and da Vinci Xi surgical systems for grasping and blunt dissection of tissue, as well as bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7mm in diameter, lymphatic vessels, and tissue bundles that fit within the instrument’s jaws. In June 2025, we obtained FDA clearance for the same instrument.
Read it in 10-K 2026-02-03 at sec.gov ↗
RemovedMD&A
COVID-19 has had a negative impact on our procedure volumes during periods with COVID-19 outbreaks due to patient delays in both the diagnosis and treatment of diseases. While such delays have negatively impacted our procedure volumes in periods with COVID-19 outbreaks, we believe that these delays have also resulted in increased procedure volumes during those periods following such outbreaks, due to the treatment of patients in backlogs that were created during the COVID-19 outbreak.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
In the first fiscal quarter of 2023, COVID-19 resurgences in China negatively impacted our procedure volumes in the region. However, as infections and hospitalization decreased, our procedure volumes recovered. We did not experience significant procedure volume disruptions due to COVID-19 outbreaks in any of our geographic markets during the remainder of 2023. Instead, throughout 2023, we saw a positive impact on procedure volumes and believe that such positive impacts were partially attributable to patients who had deferred treatment returning for diagnosis and treatment.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
During 2024, we did not experience noticeable procedure volume disruptions due to COVID-19. We also believe that a large portion of the patients in the backlog that required treatment during the COVID-19 pandemic have now been treated. Therefore, we believe that the impact of patient backlogs was less significant on procedure volumes in 2024 than what was experienced in 2023.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
In addition, historically, placements of our da Vinci surgical systems have tended to be heavier in the fourth quarter and lighter in the first quarter, as hospital budgets are reset.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
•In February 2022, we received regulatory clearance in China to market both our 12 mm SureForm 45 stapler and SureForm 60 stapler and corresponding reloads.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
•In January 2022, we received regulatory clearance in China to market our da Vinci Vessel Sealer Extend with up to 7 mm vascular indications.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
Refer to the descriptions of our new products that received regulatory clearances, approvals, or certifications in 2024, 2023, and 2022 in the Recent Product Introductions section below.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
Da Vinci 5. Da Vinci 5 builds on da Vinci Xi’s highly functional design, featuring force feedback technology and instruments that enable surgeons to sense and measure the force exerted on tissue during surgery. It also includes new surgeon controllers, powerful vibration and tremor controls, a next-generation 3D display and image system, and throughput and workflow enhancements, such as an integrated electrosurgical unit and insufflation capabilities technology. Da Vinci 5 has more than 10,000 times the computing power of da Vinci Xi, allowing for innovative new system capabilities and advanced digital experiences, including integration with our My Intuitive app, SimNow (virtual reality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system). Additionally, the redesigned console provides greater surgeon comfort with customizable positioning, allowing surgeons to find their best fit for surgical viewing and comfort, including the ability to sit completely upright.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
E-200 Generator. The E-200 generator is an advanced electrosurgical generator designed to provide high-frequency energy for cutting, coagulation, and vessel sealing of tissues. The E-200 generator is integrated with the da Vinci 5 surgical system, is compatible with the da Vinci X and Xi surgical systems, and can also function as a standalone electrosurgical generator. When connected to a da Vinci system, the E-200 delivers high-frequency energy to da Vinci instruments, with control and status messages communicated through an Ethernet cable. The E-200 generator is also compatible with third-party handheld monopolar and bipolar instruments, as well as fingerswitch-equipped instruments and Intuitive-provided auxiliary footswitches.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
The E-200 generator includes the same advanced energy capability as the E-100 generator and supports the same vessel sealing instruments.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
SureForm 30 Curved-Tip Stapler and Reloads. The 8 mm SureForm 30 Curved-Tip stapler and reloads (gray, white, and blue) was designed to help surgeons better visualize and reach anatomy through a combination of the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation, and the curved tip. As it fits through the 8 mm da Vinci surgical system instrument cannula, the stapler allows different angles for surgeons to approach patient anatomy. Consistent with our other SureForm staplers, the 8 mm SureForm 30 Curved-Tip stapler integrates SmartFire technology, which makes automatic adjustments to the firing process as staples are formed and the transection is made. The technology makes more than 1,000 measurements per second, helping achieve a consistent staple line.
Read it in 10-K 2025-01-31 at sec.gov ↗
RemovedMD&A
The following table sets forth, for the years indicated, certain Consolidated Statements of Income information (in millions, except percentages):
Read it in 10-K 2025-01-31 at sec.gov ↗
RewordedMD&A
Inventory, including the transfer of equipment from inventory to property, plant, and equipment of $615 million, partially offset by the transfer of property, plant, and equipment to inventory of $44 million, Inventory increased by $830 million, $1.06 billion, primarily to address the growth in our business, expand our leasing business, business and to mitigate risks of disruption that could arise from global supply chain shortages and manufacturing line transfers. shortages.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
Operating lease revenue, including the contribution from Ion systems, was $874 million for 2025, of which $531 million was variable lease revenue related to usage-based arrangements, compared to $654 million for the year ended December 31, 2024, of which $338 million was variable lease revenue related to usage-based arrangements, compared to $501 million for the year ended December 31, 2023, of which $217 million was variable lease revenue related to usage-based arrangements.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
We generally do not provide specified-price trade-in rights or upgrade rights at the time of a system purchase; however, we expect that in conjunction with the number of arrangements that may contain these specified-price trade-in rights will increase as we continue the phased launch rollout of our next-generation multi-port platform, da Vinci 5. 5 surgical system, there may be limited instances in which certain arrangements include specified-price trade-in rights.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
The increase in research Research and development expenses for the year ended December 31, increased in 2025 compared to 2024, was primarily driven by higher headcount and personnel-related expenses, including share-based compensation expense, and other project costs incurred to support a broader set of product development initiatives. initiatives and higher headcount and personnel-related expenses, including share-based compensation expense.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
Management believes that the installed base, number and type of placements, and utilization of systems procedures provide meaningful supplemental information regarding our performance, as management believes that the installed base, number of placements, and utilization of systems are indicators procedure volume is an indicator of the rate of adoption of our robotic-assisted medical procedures as well as an indicator of future recurring revenue. revenue (including revenue from usage-based operating lease arrangements).
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
The higher system revenue for the year ended December 31, 2024, 2025, was primarily driven by an increase in da Vinci surgical system placements, including a decrease in the proportion of da Vinci surgical system placements under operating leases, higher operating lease revenue, higher ASPs, and higher lease buyout revenue, partially offset by a higher proportion of da Vinci system placements under operating leases. ASPs.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
The increase in selling, Selling, general and administrative expenses for the year ended December 31, increased in 2025 compared to 2024, was primarily driven by higher headcount and personnel-related expenses, including share-based compensation expense, expense and variable compensation expenses, and a higher litigation charges, and higher legal expenses. charitable contribution to the Intuitive Foundation.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
We also In May 2025, we obtained FDA clearance for the use of our da Vinci SP surgical system in transvesical approaches transanal local excision/resection, a form of minimally invasive surgery performed through a natural orifice to simple and radical prostatectomy. avoid abdominal surgical incisions, for select procedures.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
Year Ended December 31, 2025 2024 2023 2022 Da Vinci Surgical System Placements Under Leasing Arrangements Fixed-payment operating lease arrangements 376 309 304 276 Usage-based operating lease arrangements 496 467 355 216 Total da Vinci surgical system placements under operating lease arrangements 872 776 659 492 % of Total da Vinci surgical system placements 51% 51% 48% 39% Sales-type lease arrangements 40 88 45 99 Total da Vinci surgical system placements under leasing arrangements 912 864 704 591 Ion System Placements Under Leasing Arrangements Fixed-payment operating lease arrangements 43 85 63 61 Usage-based operating lease arrangements 53 68 54 40 Total Ion system placements under operating lease arrangements 96 153 117 101 % of Total Ion system placements 49% 56% 55% 53% Sales-type lease arrangements 10 4 5 11 Total Ion system placements under leasing arrangements 106 157 122 112
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RewordedMD&A
We provide sell our products and services through direct sales organizations in the U.S., Europe (excluding Italy, Spain, Portugal, Greece, and Eastern European countries), China (through our Intuitive-Fosun Pharma Joint Venture), Japan, South Korea, India, Taiwan, majority-owned joint ventures, Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd. and Canada. Intuitive Surgical-Fosun (HongKong) Co., Ltd.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
The increase in service revenue 2025 was primarily driven by the growth of the a larger installed base of installed da Vinci surgical systems producing service revenue. revenue and favorable product mix, particularly from da Vinci 5 surgical system placements.
Read it in 10-K 2026-02-03 at sec.gov ↗
RewordedMD&A
The increase in system placements reflects total units placed during 2025 compared to 2024, reflected incremental demand for our next-generation da Vinci 5 system surgical system, an increase in trade-ins of our fourth-generation da Vinci surgical systems, and continued demand for additional capacity by our customers as a result of procedure growth, partially offset by a smaller number of third-generation da Vinci surgical systems available for trade-in.
Read it in 10-K 2026-02-03 at sec.gov ↗
