Johnson & Johnson’s Ottava Surgical Robot Wins FDA Nod

Johnson & Johnson has been granted de novo authorization for its Ottava robotic surgical system, which the company touts as the world’s first table-integrated soft tissue robotic system.

Ottava obtained marketing authorization for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

The surgical robot’s architecture occupies 30-50% less space that traditional boom- and cart-mounted system to create more space for surgeons and clinical teams to move, communicate, and care for patients. Software controls coordinate the four table-integrated arms, allowing automated, predefined procedural poses. Twin motion provides patient repositioning and multi-quadrant access to anatomy with limited intra-operative adjustments.

Ottava’s instrumentation portfolio was reimagined to drive innovation for the more typically used surgical tools. The system boasts a two-in-one needle driver to reduce unintended suture cutting, and monopolar curved scissors for consistent, complete cuts.

It’s connected to J&J’s Polyphonic digital ecosystem, a solution to bring learning, media, and data-driven insights together to support continuous improvement. Developed with clinicians, educational experts, and surgical societies, Ottava education aims to support safe adoption and consistent performance via virtual, hands-on, and immersive training.

J&J will launch the Ottava system with select U.S. customers to focus on early customer success while moving into further indications and regulatory jurisdictions over time. A U.S. clinical trial for inguinal hernia procedures in in progress.

Comments from Johnson & Johnson execs

Tim Schmid, executive VP, worldwide chairman, MedTech: “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.”

Hani Abouhalka, company group chair, Surgery, MedTech: “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.”

Peter Schulam, MD, Ph.D., chief scientific officer, MedTech: “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.”