Johnson & Johnson’s Ottava surgical robot begins first clinical trial cases

USA – Johnson & Johnson MedTech has reached a major milestone with its Ottava surgical robot, marking the start of its first clinical trial procedures.

The early-stage surgeries were successfully performed by Dr. Erik Wilson, a leader in minimally invasive surgery, at Memorial Hermann-Texas Medical Center.

Dr. Wilson, who also heads the department of minimally invasive and general elective surgery at UT Health Houston, completed Roux-en-Y gastric bypass surgeries using Ottava. These surgeries are the first ever done using J&J’s highly anticipated robotic system.

“Surgical robotics is leading the way in modern, minimally invasive surgery,” said Dr. Wilson in a statement. “It’s an honor to be the first to use Ottava in clinical cases and contribute to the future of surgical robotics.”

A new era in robotic-assisted surgery

Ottava is designed to handle a variety of soft-tissue surgeries. Its key feature is flexibility—allowing the surgical team to move freely, collaborate easily, and adapt to patient needs during complex operations.

Johnson & Johnson believes this robot could support procedures that span multiple regions of the body—especially in the upper abdomen.

These first cases are part of a clinical study intended to collect evidence on how well Ottava performs across different procedures.

Once the study is complete, the company plans to seek FDA de novo authorization, targeting approval for several types of general surgeries, including gastric sleeve, small bowel resection, hiatal hernia repair, and gastric bypass.

“We’re proud to hit this critical point in our robotic surgery journey,” said Hani Abouhalka, Group Chair of Surgery at J&J MedTech.

“Ottava is a major addition to our line of advanced surgical tools, and it reflects our commitment to raising surgical standards for patients around the world.”

The evolution of Ottava

Ottava has been in development since it was first introduced over four years ago. Originally shown in 2020, the robot boasted a six-arm setup.

However, J&J later revised the design, revealing in late 2023 a more streamlined version with four robotic arms that are integrated directly into a standard-size surgical table. These arms can be deployed when needed and neatly tucked away when not in use—an innovation meant to reduce clutter and improve safety in the operating room.

Though the project faced delays—mainly due to technical and development adjustments—the FDA approved J&J’s Investigational Device Exemption (IDE) in late 2024. That allowed the company to launch its clinical trials, which are now underway.

Dr. Peter Schulam, Chief Scientific Officer of J&J MedTech, emphasized the importance of this trial: “This study represents our commitment to combining biology and technology. By generating clinical data, we hope to shape the next generation of robotic-assisted surgery and improve outcomes for patients worldwide.”