Intuitive Surgical, Inc.
NasdaqGS:ISRG
$ 394.07
$-12.95 (-3.30%)
$ 394.07
$-12.95 (-3.30%)
Real-time: 03/22/2024 15:59

Intuitive Surgical Stock

About Intuitive Surgical

Intuitive Surgical, Inc. (Intuitive) develops, manufactures, and markets products and related services enable physicians and healthcare providers to improve the quality of and access to minimally invasive care. The da Vinci surgical system consists of a surgeon console or consoles, a patient-side cart, and a high-performance vision system. The Ion endoluminal system consists of a system cart, a controller, a catheter, and a vision probe. Both systems use software, instruments, and accessories. Intuitive Surgical share price history

Products

Systems

Advanced robotic systems provide precise, powerful systems with high-performance vision, extending the care team’s capabilities to enhance minimally invasive care. These systems include the da Vinci surgical system, which was designed to enable complex surgery using a minimally invasive approach, and the Ion endoluminal system, which extends the company’s commercial offerings beyond surgery into diagnostic procedures, enabling minimally invasive biopsies in the lung.

Da Vinci Surgical Systems

By striving to find less invasive ways to enter the body, provide clearer views of anatomy and more precise tissue interactions, and help hone surgical skills, Intuitive launched its first da Vinci surgical system in 1999. In 2000, the FDA cleared da Vinci for general laparoscopic surgery. Intuitive Surgical share price history

There are several models of the da Vinci surgical system: the company’s fourth generation da Vinci X, da Vinci Xi, and da Vinci SP surgical systems, its third generation da Vinci Si surgical system, its second generation da Vinci S surgical system, and its first generation da Vinci standard surgical system. The da Vinci surgical systems are designed to enable surgeons to perform a wide range of surgical procedures within its targeted general surgery, urologic, gynecologic, cardiothoracic, and head and neck specialties. As of December 31, 2023, surgeons had used the da Vinci surgical system to perform dozens of different types of surgical procedures. Da Vinci systems offer surgeons three-dimensional, high definition (3DHD) vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera (endoscope) and wristed instruments (e.g., scissors, scalpels, and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

The company’s da Vinci surgical systems consists of the following components:

Surgeon Console: The da Vinci surgical system allows surgeons to operate while comfortably seated at an ergonomic console viewing a 3DHD image of the surgical field. The surgeon’s fingers grasp instrument controls below the display with the surgeon’s hands naturally positioned relative to his or her eyes. Using electronic hardware, software, algorithms, and mechanics, the company’s technology translates the surgeon’s hand movements into precise and corresponding real-time micro movements of the da Vinci instruments positioned inside the patient. On most of the company’s systems (da Vinci X, da Vinci Xi, da Vinci SP, and da Vinci Si), a second surgeon console may be used in two ways: to provide assistance to the primary surgeon during surgery or to act as an active aid during surgeon-proctor training sessions. With the da Vinci X, da Vinci Xi, da Vinci SP, and da Vinci Si, a surgeon sitting at a second console can view the same surgery as the primary surgeon and can be passed control of some or all of the da Vinci instruments during the surgery. In addition, surgeons can control 3D virtual pointers to augment the dual-surgeon experience. The da Vinci surgical system is designed to allow surgeons to operate while seated, which may be clinically advantageous because of reduced surgeon fatigue. The da Vinci surgical system’s design provides natural hand-eye alignment at the surgeon console. Because the da Vinci surgical system’s robotic arms hold the camera and instruments steady, there is less surgeon and assistant fatigue.

Patient-Side Cart: The patient-side cart holds electromechanical arms that manipulate the instruments inside the patient. For the company’s da Vinci Xi, da Vinci X, and da Vinci Si surgical systems, up to four arms attached to the cart can be positioned, as appropriate, and then locked into place. At least two arms hold surgical instruments, one representing the surgeon’s left hand and one representing the surgeon’s right hand. A third arm positions the endoscope, allowing the surgeon to easily move, zoom, and rotate the field of vision. A fourth instrument arm extends surgical capabilities by enabling the surgeon to add a third instrument to perform additional tasks. The fourth instrument arm is a standard, integrated feature on the da Vinci X, da Vinci Xi, and da Vinci Si surgical systems. The company’s da Vinci single-port (SP) surgical system includes a single arm with three multi-jointed, wristed instruments and the first da Vinci fully wristed, 3DHD camera. The instruments and the camera all emerge through a single cannula and are triangulated around the target anatomy to avoid external instrument collisions that can occur in narrow surgical workspaces.

3DHD Vision System: The company’s vision system includes a 3DHD endoscope with two independent vision channels linked to two separate color monitors through sophisticated image processing electronics and software. The resulting 3DHD image has high resolution, high contrast, low flicker, and low cross fading. A digital zoom feature in the 3DHD vision system allows surgeons to magnify the surgical field of view without adjusting the endoscope position and, thereby, reduces interference between the endoscope and instruments. The 3DHD vision system is a standard, integrated feature on the da Vinci X, da Vinci Xi, da Vinci SP, da Vinci Si, and da Vinci S surgical systems.

Firefly Fluorescence Imaging (Firefly): Firefly is a standard feature of the da Vinci X, da Vinci Xi, and da Vinci SP surgical systems and is available as an upgrade on the company’s da Vinci Si surgical system. This imaging capability combines an injectable fluorescent dye with a specialized da Vinci camera head, endoscope, and laser-based illuminator to allow surgeons to identify vasculature, tissue perfusion, or biliary ducts in three dimensions beneath tissue surfaces in real-time. The most common procedural categories for the use of Firefly are urology, gynecology, and general surgery.

Da Vinci Xi Integrated Table Motion: Integrated Table Motion coordinates the movements of the da Vinci robotic arms with an advanced operating room (OR) table, the TS 7000dV OR Table sold by Hillrom, to enable managing the patient’s position in real-time while the da Vinci robotic arms remain docked. This gives OR teams the capability to improve the positioning of the operating table during da Vinci surgical system procedures. Integrated Table Motion enables the patient to be dynamically positioned during the procedure. It enables surgeons to extend reach, facilitate access, and choose the angle of approach to target anatomy, as well as reposition the table during the procedure to enhance anesthesiologists’ management of the patient.

Ion Endoluminal System

In 2019, the FDA cleared the company’s Ion endoluminal system, which is a flexible, robotic-assisted, catheter-based platform that utilizes instruments and accessories for which the first cleared indication is minimally invasive biopsies in the lung. The company’s Ion system extends its commercial offering beyond surgery into diagnostic, endoluminal procedures. The system features an ultra-thin, ultra-maneuverable catheter that can articulate 180 degrees in all directions and allows navigation far into the peripheral lung and provides the stability necessary for precision in a biopsy. Many suspicious lesions found in the lung may be small and difficult to access, which can make diagnosis challenging, and Ion helps physicians obtain tissue samples from deep within the lung, which could help enable earlier diagnosis.

Surgical Instruments and Accessories

The company offers a comprehensive suite of stapling, energy, and core instrumentation for its multi-port da Vinci surgical systems. The company’s technology is designed to transform the surgeon’s natural hand movements outside of the body into corresponding micro-movements inside the patient’s body and suture with precision, just as they can in open surgery. With its technology, a surgeon can also use ‘motion scaling’, a feature that translates, for example, a three-millimeter hand movement outside the patient’s body into a one-millimeter instrument movement in the surgical field inside the patient’s body. Motion scaling is designed to allow precision and control for delicate tasks. In addition, the company’s technology filters the tremor inherent in a surgeon’s hands.

Da Vinci Instruments: Most of the various instruments that the company manufactures incorporate wristed joints for natural dexterity and tips customized for various surgical procedures. Various da Vinci instrument tips include forceps, scissors, electrocautery tools, scalpels, and other surgical tools that are familiar to the surgeon from open surgery and conventional minimally invasive surgery (MIS). A variety of instruments may be selected and used interchangeably during a surgery. Most instruments are sterilizable at the hospital, while others are provided sterile, and most are reusable for a defined number of procedures. A programmed memory chip inside each instrument performs several functions that help determine how the da Vinci system and instruments work together. In addition, the chip generally will not allow the instrument to be used for more than the prescribed number of procedures to help ensure that its performance meets specifications during each procedure.

In 2020, the company announced its ‘Extended Use Program’, which consists of select da Vinci Xi and da Vinci X instruments possessing 12 to 18 uses (Extended Use Instruments) compared to the previous 10 uses. These Extended Use Instruments represent some of the company’s higher volume instruments but exclude stapling, monopolar, and advanced energy instruments. Instruments included in the program are used across a number of da Vinci surgeries. Their increased uses are the result of continuous, significant investments in the design and production capabilities of the company’s instruments, resulting in improved quality and durability. Extended Use Instruments were introduced in the U.S. and Europe in the fourth quarter of 2020 and were launched in most other countries around the world during the first half of 2021, except China, where they were launched in the second half of 2023. As of the end of 2021, in the U.S. and Europe, full cutover to Extended Use Instruments had occurred, as customers had substantially utilized all of their remaining 10 use instruments.

Da Vinci Stapling: The EndoWrist and SureForm Staplers are wristed, stapling instruments intended for resection, transection, and creation of anastomoses. These instruments enable surgeons to precisely position and fire the stapler. The company has various clearances for five staplers that can be used with the da Vinci X and da Vinci Xi surgical systems: the EndoWrist 30 and 45 staplers and the SureForm 30, 45, and 60 staplers, where the numeric designation indicates the length of the staple line. The EndoWrist 30 stapler is intended to deliver particular utility with fine tissue interaction in lobectomy and other thoracic procedures. The EndoWrist 45 stapler is used in general surgery, gynecologic, thoracic, and urologic procedures. The SureForm 30, 45, and 60 staplers are single-use, fully wristed, stapling instruments intended to be used in general surgery, thoracic, gynecologic, urologic, and pediatric surgery procedures. The SureForm 30 stapler may deliver particular utility in thoracic procedures. The SureForm 45 stapler may receive particular use in thoracic and colorectal procedures where maneuverability and visualization are limited. The SureForm 60 stapler is intended to deliver particular value in bariatric procedures. The company also has various clearances for five stapler reloads: gray (2.0 mm), white (2.5 mm), blue (3.5 mm), green (4.3 mm), and black (4.6 mm). Not all reloads are available for use on all staplers. Not all staplers or reloads are available in all countries.

Da Vinci Energy: Vessel Sealer Extend is a single-use, fully wristed, advanced bipolar instrument that is compatible with the company’s fourth-generation multi-port surgical systems. Vessel Sealer Extend is also compatible with certain third-party electrosurgical generators. It is intended for grasping and blunt dissection of tissue, bipolar coagulation, and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. This instrument enables surgeons to control vessel sealing, while providing the benefits of robotic-assisted surgery, and is designed to enhance surgical efficiency and autonomy in a variety of general surgery and gynecologic procedures.

The E-100 generator is Intuitive’s first generator and is offered as an upgrade to power the company’s da Vinci Vessel Sealer Extend and SynchroSeal instruments. SynchroSeal enables a surgeon to perform rapid, one-step sealing and transection with a single pedal press. SynchroSeal uses advanced bipolar energy from its raised cut electrode to transect tissue and then cool down quickly.

Accessory Products: The company sells various accessory products, which are used in conjunction with the da Vinci surgical systems as surgical procedures are performed. Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products, such as replacement 3D stereo endoscopes, camera heads, and light guides, and other items that facilitate use of the da Vinci surgical systems.

Learning

Intuitive provides a progressive learning journey to support the use of the company’s technology. These training pathways leverage both learning engagements and learning technologies. Learning engagement touchpoints vary by specific pathway, skill level, and interest, while learning technologies enable and provide training directly to the customer. The portfolio of learning offerings includes role-specific training pathways, learning engagements, and learning technology.

Training Pathways: Intuitive’s training pathways provide a systematic learning journey that helps customers build technical proficiency. There are pathways for surgeons and physicians, residents and fellows, OR care teams, patient side assists, and robotic coordinators, as well as recommendations for executives.

Learning Engagements: Intuitive learning engagements are touchpoints that support customers throughout their learning journeys. They vary by pathway, skill level, and focus area. Engagements include case observations, online education, in-service training, simulation/skills training, OR care team training, technology training, reprocessing training, proctoring, advanced training, and curriculum development support. Many of these programs take place at Intuitive training centers and are taught by experienced Intuitive staff, while the company’s advanced courses are taught by surgeon and physician instructors.

Learning Technology: Learning technologies are designed to help customers access training. Enabling technology helps bring innovative offerings to the customer. Intuitive’s enabling technologies include Telepresence and the Procedure Analytics Platform. Learning technology solutions include Intuitive Learning, SimNow, customized training models, remote case observations, and remote proctoring. Two of the technology solutions most often used by customers are Intuitive Learning and SimNow.

Intuitive Learning: Intuitive Learning enables customers to complete technology and procedure education, while also being able to view, assign, and track technology and simulation learning. Intuitive Learning’s user roles include surgeons/physicians, residents/fellows, care teams, patient side assists, robotic coordinators, and sterile reprocessing staff.

SimNow: The company’s cloud-enabled SimNow simulation platform is a practice tool that gives a user the opportunity to practice their skills and gain familiarity with the surgeon console controls and supports the user’s progressive learning pathway. SimNow incorporates 3D, physics-based computer simulation technology to immerse the user within a virtual environment and provides training capabilities that have been used extensively by surgeons. The user navigates through the environment and completes exercises by controlling virtual instruments from the surgeon console. Upon completion of a skills exercise, the skills simulator provides a quantitative assessment of user performance based on a variety of task-specific metrics. The SimNow online connection drives real-time simulation performance tracking for surgeons and administrators through an online dashboard and supports remote updates of the VR content and 3DHD videos to drive a more interactive and engaging customer experience. SimNow is intended to augment, not replace, existing training programs for the da Vinci X, da Vinci Xi, and da Vinci SP surgical systems.

Services

The company has a network of field service engineers across the U.S., Europe, and Asia and maintain relationships with various distributors around the globe. This infrastructure of service and support specialists offers a full complement of services for the company’s customers, including installation, repair, maintenance, 24/7 technical support, and proactive system health monitoring.

The company’s comprehensive support and program assistance helps ensure customers and care teams maximize program performance and protect their investment. Services include readiness support, maintenance support, perioperative consulting, Custom Hospital Analytics, and market consulting optimization.

Readiness and Maintenance Support: Readiness support is operational support to ensure smooth onboarding and adoption of new systems and technology. Maintenance support helps to maximize operational efficiency and reduce unplanned equipment downtime. It includes service care plans, support teams, OnSite monitoring, software upgrades and updates, as well as a customer portal. The service plan portfolio offers flexible service plans to ensure reliability of the systems and instruments and help optimize the robotics program. The support team of expert field service, remote technical support, and customer care agents resolve and prevent any technology issues that could inhibit optimal utilization. OnSite monitoring offers remote service in real-time for pre-operative and intraoperative troubleshooting, as well as proactive monitoring of system performance. Software upgrades and updates enable the latest product innovations, enhancements, and reliability improvements. The customer portal is an online tool that enables customers to access system utilization and program analytics, view orders and maintenance history, and initiate product returns and exchanges to help achieve the operational and financial goals of a robotics program.

Perioperative Consulting: Perioperative consulting is a suite of customized solutions to improve a hospital’s efficiency and performance with Intuitive technologies. New system integration support is available to streamline the start-up process and expedite increased procedure volumes. Overall program assessments help to support efficiency improvements and system access optimization.

Program Analytics: The company’s Custom Hospital Analytics program enables the integration of data sources so that individual health institutions can analyze their data in their own environment. Using this data, executives, administrators, care teams, and surgeons can gain alignment around their programs based on their KPIs, determine best practices, assess gaps, and take actionable steps to address any gaps.

Digital Solutions

Integrated digital capabilities provide connected offerings, streamlining performance for hospitals with program-enhancing insights. Secure-by-design, cloud-enabled products analyze and simplify essential data to continuously optimize the use of time, tools, and techniques.

Intuitive Hosted & Managed Services: The vast majority of the company’s systems are network connected and directly communicate with Intuitive to enable proactive monitoring, as well as provide software updates and data insights to Intuitive customers.

3D Modeling Services: Intuitive 3D Models is the company’s augmented reality imaging product for use in kidney, prostate, lung, and rectal procedures. The service extracts CT and MR scans, runs them through segmentation algorithms and, after technicians’ revision and radiologists’ review, returns a 3D segmented model of the organ for use in planning for a procedure, intraoperative visualization, and surgical education. The tool uses augmented reality to give surgeons an image with details of organ anatomy – blood vessels, tumor shape, and size – that they may not be able to see well with other imaging. Intuitive designed this to help with pre-operative planning and intraoperative guidance to let surgeons know where critical anatomy sits as they work through a procedure, as well as to be shared as a teaching tool for other physicians and patients. The product has recently been launched, and the company is in the process of bringing the first sites onboard.

My Intuitive: This mobile and web application was developed to be the single point for Intuitive customers to access individual or program-level data from Intuitive. The application also offers comparisons of those insights with anonymized national benchmarks to help drive operational efficiencies and decreased costs. It enables mobile access to Intuitive’s Learning platform, case reports generated automatically for the surgeon, and an ability for surgeons to publish their practice information online for patients seeking local physicians.

Intuitive Hub: Intuitive Hub is part of the company’s operating room (OR) informatics platform that integrates multiple applications and data sets to help orchestrate medical procedure workflows. For the care team, Intuitive Hub acts as a point-of-care device that automates tasks, such as video recording and bookmarking, and can be used to facilitate peer-to-peer collaboration by utilizing the telepresence feature. For surgeons, Intuitive Hub connects video and other data that can be accessed after a surgical procedure to help facilitate personalized learning and increased efficiency.

Business Strategy

The key elements of the company’s strategy is to enable physicians and hospitals to improve outcomes for their patients, and improve their patient’s and the care team’s experience.

The company offers physicians and their operating room staff training on the technical use of its products. The company’s da Vinci surgical system provides an ergonomic platform for surgeons to perform their procedures. It seeks to provide surgeons with reliable and easy-to-use products.

The company helps hospitals build value by increasing surgical revenue and reducing costs through lower complication rates and reduced lengths of patient stay. It also offers its Custom Hospital Analytics program, which enables the integration of data sources so that individual health institutions can analyze their data in their own environment.

Clinical Applications

The company is the beneficiaries of productive collaborations with leading surgeons in exploring and developing new techniques and applications for robotic-assisted surgery with the da Vinci surgical system and minimally invasive biopsies with the Ion endoluminal system—an important part of its creative process. The company primarily focuses its development efforts on those procedures in which its products bring the highest patient value, surgeon value, and hospital value. The company focuses on five surgical specialties: general surgery, urologic surgery, gynecologic surgery, cardiothoracic surgery, and head and neck surgery. Key procedures that the company is focused on include hernia repair, colon and rectal procedures, cholecystectomy, bariatric surgery, prostatectomy, partial nephrectomy, hysterectomy, sacrocolpopexy, lobectomy, and transoral robotic surgery. The company also focuses on minimally invasive biopsies in the lung.

Da Vinci Procedure Mix

The company’s da Vinci procedure business is broadly split into two categories: cancer procedures and procedures for benign conditions. Cancer and other highly complex procedures tend to be reimbursed at higher rates than less complex procedures for benign conditions. Thus, hospitals are more sensitive to the costs associated with treating less complex, benign conditions. The company’s strategy is to provide hospitals with attractive clinical and economical solutions across the spectrum of procedure complexity. The company’s fully featured da Vinci Xi surgical system with advanced instruments, including the da Vinci Energy and EndoWrist and SureForm Stapler products, and its Integrated Table Motion product, targets the more complex procedure segment. The company’s da Vinci X surgical system is targeted toward price-sensitive markets and procedures. Its da Vinci SP surgical system complements the da Vinci Xi and X surgical systems by enabling surgeons to access narrow workspaces.

Clinical Summary

There are over 70 representative clinical uses for da Vinci surgical systems. There are numerous additional applications that can be addressed with the da Vinci surgical system, and the company works closely with its surgeon customers to refine and explore new techniques in which a da Vinci surgical system may bring value. As of December 31, 2023, the company had an installed base of 8,606 da Vinci surgical systems, including 5,111 in the U.S., 1,617 in Europe, 1,484 in Asia, and 394 in the rest of the world. The company estimates that surgeons using its technology completed approximately 2,286,000 surgical procedures of various types in hospitals throughout the world during the year ended December 31, 2023.

As of December 31, 2023, the company had an installed base of 534 Ion systems, 531 of which are located in the U.S. The company plans to seek additional clearances, certifications, or approvals for Ion in markets outside of the U.S. (OUS) over time.

Sales Model

The company provides its products through direct sales organizations in the U.S., Europe (excluding Spain, Portugal, Italy, Greece, and Eastern European countries), China, Japan, South Korea, India, Taiwan and, since June 2022, Canada. The company provides products and services in China through its majority-owned joint venture (Joint Venture) with Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) and its affiliates. In the remainder of the company’s markets outside of the U.S., it provides its products through distributors. During the years ended December 31, 2023, domestic revenue accounted for 66% of total revenue, while revenue from the company’s OUS markets accounted for 34% of total revenue.

The company’s direct sales organization consists of a capital sales team, responsible for selling systems, and a clinical sales team, responsible for supporting the systems used in procedures performed at its hospital accounts. The company’s hospital accounts include both individual hospitals and healthcare facilities, as well as hospitals and healthcare facilities that are part of an integrated delivery network (IDN groups). The initial system sale into an account is a major capital equipment purchase by the company’s customers and typically has a lengthy sales cycle that can be affected by macroeconomic factors, capital spending prioritization, the timing of budgeting cycles, and the evaluation of alternative products. Capital sales activities include educating surgeons or physicians and hospital staff across multiple specialties on the benefits of robotic-assisted surgery with a da Vinci surgical system or robotic-assisted bronchoscopy with an Ion endoluminal system, total treatment costs, and the clinical applications that the company’s technology enables. The company also trains its sales organization to educate hospital management on the potential benefits of adopting its technology, including the clinical benefits of robotic-assisted surgery with a da Vinci surgical system or robotic-assisted bronchoscopy with an Ion endoluminal system, in the support of their Quadruple Aim objectives.

The company’s clinical sales team works on site at hospitals, interacting with surgeons or physicians, operating room staff, and hospital administrators to develop and sustain successful robotic-assisted surgery or bronchoscopy programs. They assist the hospital in identifying surgeons or physicians who have an interest in robotic-assisted surgery or bronchoscopy and the potential benefits provided by the da Vinci surgical system and the Ion endoluminal system. The company’s clinical sales team provides clinical information on robotic-assisted surgery or bronchoscopy practices and new product applications to the hospital teams. The company’s clinical sales team has grown with the expanded installed bases of da Vinci surgical systems and Ion endoluminal systems, as well as the total number of procedures performed. The company expects this organization to continue to grow as its business expands.

The company’s customers place orders to replenish their supplies of instruments and accessories on a regular basis. Orders received are typically shipped within one business day. New direct customers who purchase a system typically place an initial stocking order of instruments and accessories soon after they receive their system.

Seasonality

The company’s business is subject to seasonal fluctuations. Historically, the company’s sales of da Vinci surgical systems have tended to be heavier in the fourth quarter and lighter in the first quarter(year ended December 31, 2023), as hospital budgets are reset. In addition, the company has historically experienced lower procedure volume in the first and third quarters and higher procedure volume in the second and fourth quarters.

Customer Support

The company has a network of field service and technical support engineers across the U.S., Europe, and Asia and maintain relationships with various distributors around the globe. This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a full complement of services for the company’s customers, including installation, repair, maintenance, 24/7 technical support, and proactive system health monitoring.

Research and Development

For the year ended December 31, 2023, the company’s research and development expenses were $999 million.

Competition

The company adds new robotically controlled products (e.g., da Vinci Stapling and da Vinci Energy) that compete with product offerings traditionally within the domains of open surgery and/or conventional MIS, the company faces greater competition from larger and well-established companies, such as Johnson & Johnson and Medtronic plc.

Intellectual Property

As of December 31, 2023, the company owned more than 4,800 patents granted and still in force and more than 2,200 patents pending worldwide. The company intends to continue filing new patent applications in the U.S. and foreign jurisdictions to seek protection for its technology.

Trademarks

Intuitive, Intuitive Surgical, da Vinci, da Vinci S, da Vinci Si, da Vinci X, da Vinci Xi, da Vinci 5, da Vinci SP, EndoWrist, Firefly, Intuitive 3D Models, Intuitive Hub, Ion, My Intuitive, OnSite, SimNow, SureForm, and SynchroSeal are trademarks or registered trademarks of the company.

Government Regulation

The company’s products and operations are subject to regulation in the U.S. by the FDA and the State of California, as well as by other countries and regions in which the company markets and promote its products. Examples of standards to which the company is subject include electrical safety standards, such as those of the International Electrotechnical Commission (e.g., IEC 60601-ss series of standards), and composition standards, such as the Reduction of Hazardous Substances (RoHS) and the Waste Electrical and Electronic Equipment (WEEE) Directives applicable in the European Union (EU).

The company’s products are subject to regulation as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FFDCA), as implemented and enforced by the U.S. Food and Drug Administration (FDA). Class II medical devices are those that are subject to general controls, and most require premarket demonstration of adherence to certain performance standards or other special controls, as specified by the FDA, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. The company’s current products are subject to premarket notification and clearance under section 510(k) of the FFDCA. To obtain 510(k) clearance, it must submit to the FDA a premarket notification submission demonstrating that the proposed device is ‘substantially equivalent’ to a legally marketed predicate device.

The company’s manufacturing processes are required to comply with the Quality System Regulation (QSR). Products manufactured outside of the U.S. by or for the company is subject to the U.S. Customs and FDA inspection upon entry into the U.S. The company must demonstrate compliance of such products with the U.S. regulations and carefully document the eventual distribution or re-exportation of such products.

The company is subject to the U.S. (federal, state, local) and international laws and regulations, including those in the European Economic Area (EEA) and the U.K. regarding data privacy and security and its use of such data.

The company is subject to the European Union General Data Protection Regulation 2016/679 and applicable national supplementing laws (collectively, the EU GDPR) and to the United Kingdom General Data Protection Regulation and Data Protection Act 2018 (collectively, the UK GDPR) (the EU GDPR and the United Kingdom General Data Protection Regulation and Data Protection Act 2018 (UK GDPR) together referred to as the GDPR). The GDPR imposes comprehensive data privacy compliance obligations in relation to the company’s collection, processing, sharing, disclosure, transfer, and other use of data relating to an identifiable living individual or ‘personal data’, including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training, and audit.

The company obtained approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for its da Vinci Si surgical system in October 2012, for the company’s da Vinci Xi surgical system in March 2015, and for its da Vinci X surgical system in April 2018.

History

Intuitive Surgical, Inc. was founded in 1995. It was incorporated in 1995.

Country
Founded:
1995
IPO Date:
06/13/2000
ISIN Number:
I_US46120E6023

Contact Details

Address:
1020 Kifer Road, Sunnyvale, California, 94086-5304, United States
Phone Number
408 523 2100

Key Executives

CEO:
Guthart, Gary
CFO
Samath, Jamie
COO:
Data Unavailable