Johnson & Johnson announced that the company has submitted its Ottava robotic surgical system to the U.S. Food and Drug Administration (FDA) in an application for De Novo classification.

The company leveraged data from its investigational device exemption (IDE) study to apply for marketing authorization in multiple procedures in general surgery in the upper abdomen. The first cases in the Ottava IDE study were completed in early 2025 at Memorial Hermann-Texas Medical Center by Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery UT Health Houston and the lead investigator for the clinical study.

“We have taken learnings from Johnson & Johnson’s 140 years in surgery, our decades of leadership in minimally invasive surgery, and the experiences robotic surgeons and hospitals have had over the past 20 years to design a soft tissue robotic system built for the future of surgery,” said Hani Abouhalka, company group chair, Surgery, MedTech, Johnson & Johnson. “I am proud of the design decisions and major scientific efforts that have gone into the system to support surgeons and successfully complete our first clinical trial, and I look forward to reaching the next milestone on our path to commercialization.”

Ottava boasts a unified architecture, surgical instrumentation powered by Ethicon’s expertise, and future connection to the Polyphonic digital ecosystem. J&J filed data from the trial to showcase safety and effectiveness and support the system’s ability to perform a variety of surgeries. Because of the novel architecture and differentiated technological capabilities, the company filed a De Novo classification request.

J&J is targeting an indication for multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.

“The IDE study builds on a significant body of preclinical evidence we have generated demonstrating the impact of the OTTAVA system and provides critical clinical evidence on the system performance,” said Peter Schulam, M.D., Ph.D., chief scientific officer, MedTech, Johnson & Johnson. “Surgeon investigators across several hospitals led this important study to further clinical evidence in support of minimally invasive, robotic-assisted surgery for the benefit of clinical teams, hospitals, and patients.”

Ottava is engineered as a multi-specialty soft-tissue surgery robot that supports a wide range of procedures across patient anatomy and surgical specialties—including the most complex surgeries that need a multi-quadrant approach. Late last year, J&J earned IDE approval to begin a clinical trial for Ottava in inguinal hernia procedures.