Johnson & Johnson Receives FDA Approval for Surgical Robot

July 22, 2026July 22, 2026

Johnson & Johnson has received USFDA De Novo authorization for its OTTAVA™ Robotic Surgical System, marking the company’s official entry into the fast-growing soft-tissue robotic surgery market. 

The approval comes after more than a decade of research and development and positions J&J to compete with established players in robot-assisted surgery.

The OTTAVA system is the world’s first table-integrated soft-tissue surgical robot, featuring robotic arms built directly into the operating table. 

This innovative design reduces the system’s operating room footprint by 30% to 50%, allowing hospitals to optimize space while improving surgical workflow. The platform has been cleared for several general surgical procedures, including gastric bypass, sleeve gastrectomy, gallbladder removal, appendectomy, and hiatal hernia repair.

Johnson & Johnson plans to begin a phased commercial rollout of OTTAVA with select healthcare providers in the United States before expanding to additional hospitals, surgical specialties, and international markets. 

The approval follows successful clinical studies that demonstrated the system’s safety and performance in minimally invasive procedures.

The authorization represents a major milestone for J&J’s MedTech division as it enters a market currently dominated by robotic surgery platforms used in hospitals worldwide. Growing demand for minimally invasive procedures, shorter patient recovery times, and improved surgical precision is expected to drive continued adoption of robotic-assisted surgery over the coming years.

With FDA approval secured, OTTAVA strengthens Johnson & Johnson’s position in advanced medical technology and opens new growth opportunities in one of the fastest-expanding segments of the global healthcare industry.

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