Johnson & Johnson Receives FDA Market Authorization for OTTAVA Robotic Surgical System

Johnson & Johnson has received U.S. Food and Drug Administration (FDA) De Novo authorization for its OTTAVA™ Robotic Surgical System, establishing the world's first table-integrated soft tissue robotic platform.

The system is authorized for general surgery procedures within the upper abdomen, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

Featuring robotic arms integrated into the operating table, OTTAVA occupies 30–50% less space than traditional boom- or cart-mounted systems, optimizing operating room space and clinical movement.

Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, Johnson & Johnson, stated:

"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."

The platform integrates four coordinated robotic arms with twin motion technology for synchronized table and arm movement, streamlining multi-quadrant anatomical access and patient repositioning.

Additionally, OTTAVA incorporates specialized instrumentation—including a two-in-one needle driver and monopolar curved scissors—and connects directly to the Polyphonic™ digital ecosystem for surgical data insights.

Hani Abouhalka, Company Group Chair, Surgery, MedTech, Johnson & Johnson, stated:

"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."

Johnson & Johnson will launch OTTAVA commercially with select U.S. hospitals while advancing ongoing clinical trials for inguinal hernia procedures.