Johnson & Johnson announced that the U.S. Food and Drug Administration has granted De Novo authorization for the OTTAVA Robotic Surgical System, which the company describes as the world’s first table-integrated soft tissue robotic system. The system received marketing authorization for multiple general surgery procedures, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.
Johnson & Johnson will commercially launch OTTAVA with select customers in the U.S., focusing on early customer success while working to expand into additional indications and regulatory jurisdictions over time; a U.S. clinical trial for OTTAVA in inguinal hernia procedures is already underway. The system’s architecture integrates four robotic arms directly into the operating room table, occupying 30 to 50 percent less space than traditional boom- and cart-mounted systems, according to the company’s claims support documentation. Its software enables automated, pre-defined procedural poses to simplify setup and breakdown, along with “twin motion” that synchronizes table and arm movement for patient repositioning and multi-quadrant access with limited intraoperative adjustments.
The instrumentation portfolio includes a two-in-one needle driver designed to reduce unintended suture cutting and monopolar curved scissors intended to deliver consistent, complete cuts. The system connects to Polyphonic for OTTAVA, a digital ecosystem designed to bring learning, media, and data-driven insights together to support continuous improvement throughout the surgical journey, alongside an education program developed with clinicians, educational experts, and surgical societies to support virtual, hands-on, and immersive training.
Johnson & Johnson will host an investor conference call on August 3, 2026, at 8:00 a.m. Eastern Time to discuss the announcement.
KEY QUOTES:
“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 Johnson & Johnson.”
Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, Johnson & Johnson
“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. 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.”
Hani Abouhalka, Company Group Chair, Surgery, MedTech, Johnson & Johnson
“Variability of surgical outcomes remains a challenge in healthcare. While surgical robotics has helped augment surgical skill, the next generation of care must also integrate data and insights across the surgical ecosystem to support surgeon judgement and help improve patient outcomes. OTTAVA was designed with that connectivity in mind.”
Peter Schulam, M.D., Ph.D., Chief Scientific Officer, MedTech, Johnson & Johnson
