Following years of anticipation, Johnson & Johnson (J&J) MedTech’s OTTAVA robot has secured de novo classification from the US Food and Drug Administration (FDA), setting the stage for the life sciences giant to enter the burgeoning surgical robotics market in the US.
Ottava’s de novo classification follows the system’s receipt of an investigational device exemption from the FDA in November 2024 that granted J&J the ability to conduct clinical trials at US sites to support the robot’s market clearance. FDA authorisation covers the soft tissue robotic system for use in multiple general surgery procedures, including gastrectomy, splenectomy, small bowel resection, and appendectomy.
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Tim Schmid, executive vice president and worldwide chairman, J&J MedTech, commented: “We are pioneering a new category of surgical robotics with Ottava.
“This is the start of the next era in surgery as we deliver not just a new surgical robotics system, but a catalyst for fundamentally better surgical care that is informed by technology, guided by clinical insight, and delivered with care by J&J.”
Regarding Ottava’s US market launch, J&J did not disclose a specific timeframe but said it would first launch the robot with “select” US customers, with a focus on “early customer success” while working in parallel to advance into additional indications and regulatory jurisdictions over time.
J&J’s plans to market its surgical robot, pitting it against established US market players such as Intuitive Surgical, have been a long time coming. The company first shared details on Ottava around 2022, yet delays, with J&J citing the Covid-19 pandemic and technical challenges as mitigating factors, have pushed back the robot’s roadmap to market launch.
Receiving FDA clearance for its respective systems in 2025, other players vying to enter the robotic surgery market include Microbot and the UK’s CMR Surgical.
Robotic surgery is on a rapid growth trajectory, with GlobalData analysis revealing that the global market is growing at a CAGR of 5.6% and is forecast to reach a valuation of around $20.8bn in 2035, up from around $12bn in 2025. Intuitive, famous for its line of da Vinci robots, held a commanding 57.6% share of the US robotic surgical systems market in 2025, followed by Stryker and J&J’s own subsidiary, Auris Health, in a distant second and third place, respectively.
