Johnson & Johnson MedTech announced completion of the first cases in the clinical trial for its Ottava robotic surgical system. These cases are the first clinical experience with Ottava.

Ottava is a multi-specialty, soft-tissue surgery robot that supports a range of procedures across patient anatomy and surgical specialties. According to J&J, this includes the most complex surgeries that necessitate a multi-quadrant approach.

When this study is completed, the company plans to submit Ottava for de novo authorization in the U.S. J&J will target an indication covering general surgery procedures in the upper abdomen like gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair.

Ottava earned investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in late 2024. The system touts unified architecture, surgical instrumentation from Ethicon, and future connection to the Polyphonic digital ecosystem.

Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery UT Health Houston and the lead investigator for the clinical study, performed Roux-en-Y gastric bypass surgery using the Ottava Robotic Surgical System at Memorial Hermann-Texas Medical Center.

“Surgical robotics is at the forefront of innovation in minimally invasive surgery,” Dr. Wilson said. “I am proud to have performed the first clinical study cases with Ottava and potentially help advance the standard in surgical robotics.”

“We are proud to reach this important milestone in our robotic surgery program,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “Ottava is a key innovation in our portfolio of advanced surgical technologies—all of which are designed to transform the surgical experiences across all surgery. Our people work side-by-side with surgical teams in ORs around the world every day to raise the standard of care for patients and deliver what’s next in surgery.”