After nearly a decade of build up, Johnson & Johnson has announced FDA De Novo authorization for the OTTAVA Robotic Surgical System, the world’s first table-integrated soft tissue robotic system.
FDA has granted the device marketing authorization for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.
Johnson & Johnson plans to roll out the OTTAVA system through a controlled commercial launch with select U.S. customers, prioritizing early adoption success while simultaneously pursuing expanded indications and international regulatory approvals.
The company is also conducting a U.S. clinical trial evaluating OTTAVA for inguinal hernia procedures.
“"This is an incredible moment for not only the OTTAVA team, but the whole Johnson & Johnson organization," Rocco De Bernardis, Global President of OTTAVA, told
MD+DI.
"It's very differentiated versus anything else that is available on the market today. It is the world's first table-integrated soft tissue robotic system. It's the way we're signaling to the market that we're planning to extend our 140 years of leadership in surgery and really co-create with leading surgeons around the world what's next in surgery and start to get a new era for surgery."
OTTAVA system designed for current and future surgical needs
OTTAVA is designed to address both current surgical needs and future innovations. The system's distinctive architecture, automation capabilities, advanced robotic instruments, and integration with an open digital ecosystem allow it to fit into today's operating rooms while supporting the evolution toward more digitally connected, data-driven surgical care.
As hospitals work to advance surgical care while managing constraints around infrastructure, OR efficiency, data access, and rising demand for robotic-assisted procedures, OTTAVA aims to address these challenges with features designed to expand OR capacity, streamline workflows, improve data visibility, and broaden access to robotic surgery.
Key features of J&J's robotic surgical platform
Key features of the first-generation system include a compact footprint: OTTAVA integrates robotic arms directly into the OR table, occupying 30–50% less space than traditional boom- and cart-mounted systems.
Automation capabilities: Sophisticated software coordinates the four table-integrated arms, enabling automated, pre-defined procedural positions to simplify setup and breakdown.
Advanced instrumentation: Drawing on decades of experience in open and laparoscopic surgery, J&J has redesigned commonly used surgical tools for robotic applications. Notable innovations include a two-in-one needle driver engineered to reduce unintended suture cutting and monopolar curved scissors designed for consistent, complete cuts.
Digital integration: OTTAVA connects to J&J's Polyphonic digital ecosystem, a secure platform that consolidates learning resources, media, and data-driven insights to support continuous improvement throughout the surgical process.
Comprehensive training: Leveraging J&J's educational expertise, the OTTAVA training program was developed with clinicians, educational specialists, and surgical societies. The curriculum supports both new and experienced robotic surgeons through virtual, hands-on, and immersive training designed to ensure safe adoption and consistent performance.
Johnson & Johnson
first announced Ottava in late 2020
; a moment that many investors and industry professionals had been waiting for.
Johnson & Johnson is making a calculated entry into the surgical robotics market at a time when Intuitive Surgical has maintained dominant control for more than two decades, holding approximately 80% market share with its da Vinci system.
While several competitors—including
Medtronic with Hugo
,
CMR Surgical with Versius
, and others—have attempted to challenge Intuitive's position with varying degrees of success, J&J is leveraging its century-long legacy in surgical innovation, global scale, and deep relationships with hospitals and surgeons to differentiate its approach.
As a result of the announcement, shares for both Intuitive Surgical and Medtronic have declined.
The company is positioning OTTAVA not as a direct da Vinci competitor, but as a "new category" in soft tissue robotics, emphasizing its space-saving table-integrated design, automation features, and connection to an open digital ecosystem as key differentiators.
"We're not sharing specific details on the commercial plans, but what I can tell you is that we might not be the first, we're not definitely the first in this space, but we're coming to market to lead in this space," De Bernardis said. "And we have very bold plans for OTTAVA and beyond to extend our leadership in surgery into robotics."
Surgical robotics market presents high barriers to entry
This strategic framing, combined with J&J's controlled commercial launch focused on early customer success, suggests the company is taking a measured, long-term approach to capturing market share in one of medtech's most lucrative but challenging segments, particularly as the
cautionary tale of Vicarious Surgical's recent dissolution
underscores the significant barriers to entry in surgical robotics.
"Having the backing of J&J in such a venture is definitely an advantage," De Bernardis noted when asked about Vicarious Surgical's dissolution.
"And, to be able to succeed in this market, it requires commitment, resilience, and commitment also from an investment standpoint. It takes time to innovate, especially in our case where we decided to go a very different route from an architecture and innovation standpoint."
In May, Intuitive Surgical
rolled out over 100 updates
to its da Vinci 5 robotic surgery platform — including enhanced telepresence, extended-use instruments, and improved cybersecurity — as the company began facing faster-growing competition from Medtronic and J&J.
In addition, Metronic
recently filed submission to FDA
for Hugo RAS for the general surgery and gynecologic indications.
Table-integrated design creates new category in robotic surgery
When asked what makes OTTAVA a category creator rather than just another competitor, De Bernardis explained: "If you look at the current configuration architectures that are available today, they are either boom-based or cart-based, and they all require a lot of manual intervention by the surgical team. They occupy a lot of space. They hinder visibility and communication. They're complex to manage and adopting robotic systems is not an easy task for surgical teams around the world."
"OTTAVA not only brings a minimal footprint into the operating room, 30% to 50% smaller than any robotic leading robotic system out there, it also brings automation from day one," he continued.
"And automation is going to be a key component of our future innovation. OTTAVA is a platform that is meant to evolve over time, to grow its capabilities, and automation is definitely one of the key components of that. And the way we're thinking about it is how we simplify the utilization, set up, turn down, turnover of a robotic OR, and how we make every OR a robotic OR through our capabilities."
Robotic arms integrate into OR table to reduce surgical friction
The table-integrated design that J&J has championed represents a fundamental departure from traditional robotic surgery architecture.
By integrating the robotic arms directly into the operating table rather than using separate booms or carts, OTTAVA aims to reduce what
Hani Abouhalka, group chairman of surgery and robotics at J&J MedTech, describes as
"the tension and friction between the surgical team and the robot."
This approach allows the arms to retract invisibly when not needed, enabling the same OR to serve open, laparoscopic, and robotic procedures without requiring dedicated robotic suites.
"Right now, if you go to a hospital, robotic ORs have to be dedicated to robotics. We believe that ORs should be ORs to serve all surgery, whether it's open, laparoscopic, and robotics," De Bernardis said.
"Our solution, OTTAVA, the arms are integrated on the table. When you don't need them, they're stored invisibly, you don't see them. When you need them, you can deploy one or multiple arms based on the need of the surgery."
De Bernardis emphasized the importance of bringing J&J's instrumentation legacy to robotics: "The third element that is important, that's going to be really differentiating ourselves is our ability to bring a wealth of clinical expertise and innovation from Ethicon on to OTTAVA. This is what surgeons have been demanding for many, many years. And we're excited about the fact that we've integrated innovation pipelines in our team to drive innovation across open lab and robotics consistently so that surgeons using our technologies know what to expect. They know and trust that we're going to deliver to them our best technologies."
With 25% of surgeries still resulting in post-operative complications, J&J believes that bringing trusted instrumentation and consistent performance across open, laparoscopic, and robotic approaches will differentiate OTTAVA both clinically and economically. This strategy reflects the company's confidence that it can "disrupt and change surgery" as it has for the past 140 years.
Digital ecosystem integration sets OTTAVA apart
Beyond hardware, J&J is betting on digital integration as a key differentiator. "Last but not least, we have integrated OTTAVA with our polyphonic ecosystem, our open and secure digital ecosystem around OTTAVA," De Bernardis explained.
"This is the application that surgeons are going to use who are now interacting with OTTAVA. This is how they prepare for a procedure. This is how they're going to be learning and be better in what they do in their practice. This is how we're going to be collecting data from very different data sources, from J&J devices, non-J&J devices in the operating room, and turning those data points that today are completely unutilized into meaningful insights for them."
"We're also open to innovation. We're open to third parties, to surgical innovators who want to use the data that we're going to be providing to them to drive automation, AI, new algorithms, and new solutions for surgery. So it becomes really a platform for innovation as well," he added.
Clinical trial results support FDA authorization
FDA authorization follows promising results from OTTAVA's first clinical study, a prospective, multicenter trial evaluating the system's safety and performance in Roux-en-Y gastric bypass procedures.
Presented at the 2026 American Society for Metabolic and Bariatric Surgery annual meeting in May, the 30-patient study met its primary safety and performance endpoints through 30 days post-procedure, with all procedures completed robotically without conversion to a non-robotic approach.
In five of the six sites, procedures were performed in ORs that had never been used for robotic surgery, including rooms previously considered too space-constrained for robotic systems.
"These results further illustrate how novel architecture supports a differentiated approach where it matters most: in real operating rooms, with real patients," said
Peter Schulam, MD, PhD, chief scientific officer in J&J's MedTech division
. "At each step—from bench to preclinical and now human trial—we have observed that this system can allow more hospital ORs to accommodate robotics."
Controlled U.S. launch strategy prioritizes customer success
J&J's approach to commercialization reflects lessons learned from watching competitors enter the market. "We understand that this is a very different technology, and we want to make sure that, first of all, we partner with leading institutions in the U.S. who are experts in robotic surgery. That's really the key important step," De Bernardis said. "We want to drive success for them, making sure that we work with them on providing additional evidence around our value proposition and differentiation, whether it's economic or clinical."
"We want to upgrade the system that is going to be in the field for them with new capabilities. OTTAVA, as I mentioned before, is a platform that is going to grow tremendously at a steady pace with new features, software capabilities, and new instrumentation," he continued. "And last but not least, we understand that OTTAVA has to be a multi-specialty robotic system. And so we're planning to expand very quickly with approved indications through additional clinical trials."
When asked about lessons learned from competitors, De Bernardis noted: "One of the things that we're definitely doing differently versus other companies is, one, we're starting in the U.S. This is the biggest, most consolidated market with the biggest experts in robotic surgery in the world. We're starting here because the opportunity is bigger, but also because we feel confident that we can go ahead and compete from day one. The second element is that we have chosen to go into general surgery, which is a less penetrated segment of the market. And quite frankly, a segment where we have a very strong legacy and equity with our customers who have been on a journey with us for so many years."
Automation features simplify OR setup and workflow
One of OTTAVA's most distinctive features is its automation capabilities, whichDe Bernardis described in detail: "With boom-based systems or cart-based systems, there is a lot of manual interaction with the system. The surgical team has to do a lot to set up the system properly at the beginning of the procedure and tear it down at the end of the procedure. With OTTAVA, we're able to set up the system through automated procedure poses based upon the specific procedure in the patient that the surgeon is treating that day. So there is no calibration, registration, there is no movement of components around the surgical table."
"By pressing a button, the position, the arms, our intelligent surgical arms go into a docking position, which is 90% the way that, you know, the ultimate position of those intelligent surgical arms. This removes a lot of variability in the surgical theater, allowing even less expert surgical team members to set it up. You don't have to have your A-team all the time in the surgical OR with you. It's so simple that pretty much anyone could be maneuvering it with sufficient training," he explained.
The system's Twin Motion feature further enhances workflow efficiency. "In the case of Twin Motion, the synchronized table motion, we're restoring the natural movement of general surgeons using our surgical system. With OTTAVA, synchronized table motion comes for every single patient with no interruption, no additional steps in the procedure. Again, it's all about ensuring uninterrupted flow in the procedure. Once you set it up, you go, you don't have to stop the procedure, adjust the system, and restart the procedure. So again, it contributes not only to the clinical benefits for the patient with easier exposure of critical structure and organs that the surgeon needs to operate, but also efficiency in the operating room at the speed at which a procedure can be performed."
J&J confident in comprehensive competitive advantage
When asked about J&J's competitive advantage beyond hardware, De Bernardis expressed confidence in the company's comprehensive approach: "What my confidence is related to, first of all, the unique architecture, the integrated architecture, and some of the elements that I mentioned before. The talent that we have assembled around the technology, the investment and commitment from a J&J standpoint. And last but not least, what's resonating a lot with hospital systems and surgeons who have been with us on the journey is that yes, we're going to be bringing a very differentiated technology, disruptive, one-of-a-kind technology to the market, but we're also thinking more broadly about surgery with open lab robotic procedures at the center, and we'll continue innovating across all of those modalities. So all of that, plus our expertise in commercial, regulatory affairs, service, training, which is still an unmet need, makes me very confident that we're going to be leaders in this space."
OTTAVA positioned as evolving platform for surgical innovation
With FDA authorization secured and initial clinical data demonstrating both safety and practical feasibility in space-constrained operating rooms, Johnson & Johnson is positioning OTTAVA as more than just another robotic surgical system—it's a platform designed to evolve.
The company's emphasis on automation, digital integration, and bringing its legacy Ethicon instrumentation to robotics signals a long-term vision that extends beyond hardware innovation to encompass the entire surgical ecosystem.
As J&J begins its controlled U.S. launch with select customers and continues clinical trials for additional indications, the surgical robotics market, long dominated by a single player, is entering a new era of competition.
Whether OTTAVA can deliver on its promise to make every OR a robotic OR and capture meaningful market share will depend not only on the technology itself, but on J&J's ability to execute on training, service, and the continuous innovation it has pledged.
For hospitals struggling with space constraints, efficiency demands, and the growing expectation for robotic-assisted surgery, OTTAVA represents a fundamentally different approach—one that could reshape how surgical teams think about integrating robotics into their daily practice.
