Johnson & Johnson (J&J) received marketing authorization from the US Food and Drug Administration (FDA) for its Ottava robotic surgical system, marking the company’s entry into the fast-growing market for robotic-assisted soft-tissue surgery.
The approval is a significant milestone for J&J’s medical technology business as it seeks to compete with Intuitive Surgical, whose da Vinci platform dominates the robotic surgery market. Medtronic’s Hugo surgical robot also received regulatory approval last year.
The FDA has authorised Ottava for several upper-abdominal general surgery procedures, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve surgery, appendectomy, and hiatal hernia repair.
J&J said the system will initially be introduced to select customers in the United States, with plans to seek approvals for additional procedures and expand into international markets, including Japan and Western Europe.
A key feature of Ottava is its compact design. Unlike conventional robotic systems that rely on boom- or cart-mounted equipment, Ottava’s robotic arms are integrated directly into the operating table. According to J&J, this reduces the system’s operating-room footprint by 30% to 50%, allowing hospitals with limited space to adopt robotic-assisted surgery.
The company said robotic systems are currently used in only about 8% of surgical procedures worldwide, indicating significant growth potential for the sector. However, analysts believe J&J faces a challenging task in competing with Intuitive Surgical’s well-established relationships with physicians and deep integration into hospital workflows and academic training programmes.
