Johnson & Johnson announced that the U.S. Food and Drug Administration has granted De Novo authorization for its Ottava robotic surgical system, cleared for multiple general surgery procedures within the upper abdomen.

The authorized procedures include Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

According to the company, Ottava integrates robotic arms directly into the operating room table, which it claims occupies 30–50% less space than traditional boom- and cart-mounted systems, based on an evaluation of available systems as of September 2025. The system features four table-integrated arms with automated procedural positioning and synchronized table and arm motion for patient repositioning.

Johnson & Johnson said it plans a commercial launch with select U.S. customers, with intentions to pursue additional indications and regulatory approvals in other markets over time. A U.S. clinical trial for Ottava in inguinal hernia procedures is ongoing.

The system connects to the company's Polyphonic digital ecosystem, described as a platform designed to provide data and workflow support for surgical teams. Johnson & Johnson also noted an associated training program developed with clinicians and surgical societies.

Johnson & Johnson will hold an investor conference call on August 3, 2026, at 8:00 a.m. Eastern Time to discuss the announcement.

Johnson & Johnson trades on the NYSE: JNJ. The information above is based on a press release issued by the company.