By: IPP Bureau
Last updated : July 24, 2026 8:21 am
De novo authorisation enables Johnson & Johnson to launch its long-awaited robotic surgery platform for general surgical procedures, challenging established players in the growing surgical robotics market
Johnson & Johnson MedTech has received de novo classification from the US Food and Drug Administration (FDA) for its OTTAVA robotic surgical system, marking a significant milestone in the company's long-awaited entry into the US surgical robotics market.
The FDA clearance authorises the soft tissue robotic system for use in multiple general surgery procedures, including gastrectomy, splenectomy, small bowel resection and appendectomy.
The approval follows the Investigational Device Exemption (IDE) granted by the FDA in November 2024, which allowed Johnson & Johnson to conduct clinical studies at US sites to support regulatory approval.
With the clearance, J&J plans to introduce OTTAVA initially to a select group of healthcare providers in the United States, focusing on early clinical adoption before expanding to additional indications and international markets. The company has not disclosed a specific commercial launch timeline.
Tim Schmid, Executive Vice President and Worldwide Chairman, Johnson & Johnson MedTech, said, "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.”
OTTAVA has been in development for several years, with Johnson & Johnson first outlining its vision for the platform around 2022. However, the programme faced multiple delays due to the COVID-19 pandemic and technical challenges, postponing its anticipated market launch.
The approval positions Johnson & Johnson to compete more directly with established robotic surgery companies, particularly Intuitive Surgical, whose da Vinci robotic platforms dominate the US market.
Other companies expanding into the segment include CMR Surgical of the UK and Microbot, both of which also achieved key regulatory milestones in 2025.