Johnson & Johnson has received FDA De Novo authorisation for its OTTAVA™ Robotic Surgical System, clearing the way for the commercial launch of its table-integrated soft tissue robotic platform in the US.
The approval covers multiple general surgery procedures involving the upper abdomen, including Roux-en-Y gastric bypass, cholecystectomy, splenectomy, sleeve gastrectomy, appendectomy and hiatal hernia repair. The authorised indications also extend to small bowel resection, lysis of adhesions and fundoplication.
The company said it will initially roll out the system with a select group of US customers while continuing to pursue additional regulatory approvals and clinical indications. A US clinical trial evaluating OTTAVA for inguinal hernia procedures is ongoing.
Unlike conventional robotic systems, OTTAVA integrates its robotic arms directly into the operating table, reducing the overall system footprint by an estimated 30–50%. The design is intended to improve operating room flexibility, streamline clinical workflows and enhance collaboration among surgical teams.
The platform also features automated positioning, synchronised table and arm movement, and connectivity with the company’s Polyphonic™ digital ecosystem, which provides access to surgical data, education and workflow support.
Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, J&J, said: “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.”
J&J said OTTAVA has been built to help hospitals meet growing demand for robotic-assisted procedures while encouraging wider adoption of minimally invasive surgery. The company will also provide training programmes for surgeons to support implementation of the platform.
Hani Abouhalka, Company Group Chair, Surgery, MedTech, J&J, said: “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.”
Featured Image: Damian on Adobe Stock
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