J&J Enters US Robotic Surgery Market as FDA Authorizes OTTAVA Robotic Surgical System
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J&J has also indicated plans to accelerate launches in key international markets, including Japan and Western Europe, as it expands the platform's clinical applications.
Johnson & Johnson has entered the US robotic surgery market after receiving FDA marketing authorization for its OTTAVA robotic surgical system.
Initially cleared for multiple upper abdominal general surgery procedures, the system will be introduced to select healthcare providers before expanding to additional indications and international markets.
"We are pioneering a new category of surgical robotics with OTTAVA," said Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, Johnson & Johnson. "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 Johnson & Johnson."
Unlike conventional robotic systems that use large boom-mounted or cart-based configurations, OTTAVA integrates its robotic arms directly into the operating table.
According to the company, this architecture reduces the system's footprint by 30% to 50%, potentially allowing robotic-assisted surgery in operating rooms that previously lacked sufficient space.
The platform also includes automated arm positioning, synchronized table movement, redesigned robotic instruments, and connectivity with J&J's Polyphonic digital ecosystem to support workflow efficiency, education, and data-driven surgical insights.
"Surgical robotics will play an increasingly important role in surgical care, but it's clear that what defined the last 25 years of surgery will not define the next 25," said Hani Abouhalka, Company Group Chair, Surgery, MedTech, Johnson & Johnson. "By opening up the way we think about architecture, data, and the very workflows of surgery itself, we have designed OTTAVA to deliver clinical and economic benefits and support surgeons and hospitals as the future of surgery unfolds."
The FDA has granted De Novo authorization for OTTAVA to perform multiple general surgery procedures involving the upper abdomen, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve surgery, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.
The company has confirmed that commercialization will begin with selected US hospitals while additional regulatory approvals and clinical studies continue.
An ongoing US clinical trial evaluating OTTAVA for inguinal hernia repair is expected to support a future regulatory submission.
J&J has also indicated plans to accelerate launches in key international markets, including Japan and Western Europe, as it expands the platform's clinical applications.
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