Johnson & Johnson wins FDA authorization for its robotic surgery device

Johnson & Johnson has officially obtained the green light to enter the U.S. robotic surgery market, currently dominated by Intuitive ​Surgical.

The $600 billion market cap company has been granted a De Novo authorization for its OTTAVA™ Robotic Surgical System by the U.S. Food and Drug Administration (FDA), according to a Wednesday announcement.

J&J said the marketing authorization allows the robot for use in ten general surgery procedures in the upper abdomen, including gastrectomy, cholecystectomy, and splenectomy, among others.

The de novo classification clears the path for the world’s second-largest pharmaceutical firm to compete in the U.S. surgical robot market with its OTTAVA.

The company claims OTTAVA is the world’s first table-integrated soft tissue robotic system. It occupies 30–50% less space than traditional boom- and cart-mounted systems, the announcement reads.

J&J is planning a U.S. commercial launch of the robot first, with only a select group of customers, with future plans to improve the system and expand to other markets over time.

Intuitive ​Surgical faces a major competitor

OTTAVA is entering a relatively new market currently dominated by Intuitive ​Surgical’s da Vinci system.

Intuitive ​Surgical is one of the pioneers of the industry, and so happens to have amassed a large user base. As of June, there were reportedly 11,395 da Vinci systems installed in hospitals around the world, with millions of procedures already performed.

In the first quarter alone, 431 da Vinci systems were installed.

Intuitive Surgical beat expectations on both earnings and revenue for Q2 2026, driven by an 18.5% year-over-year revenue increase to $2.89 billion.

It’s left to see how the U.S. surgical robot market evolves with the second-biggest pharma company in the picture, which has since been seeking to officially join the market.

J&J submission for OTTAVA with the FDA came in early January, after another major competitor, Medtronic, secured a clearance in December for its Hugo robotic surgery system in urologic procedures.