Johnson & Johnson's OTTAVA Robot Submitted to US FDA
8 January 2026
Global medical and surgical powerhouse Johnson & Johnson has submitted their long-awaited entry into the robotic surgery market, the OTTAVA (TM) Robotic Surgical System to the U.S. Food and Drug Administration. They are applying for a De Novo classification, which allows 'low-risk' new technology devices to be marketed in the US, before final clearances are determined.
From the J & J Release:
"New Brunswick, N.J., Jan. 7, 2026 – Johnson & Johnson today announced that the company has submitted the OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration (FDA) in an application for De Novo classification. Leveraging data from the Investigational Device Exemption (IDE) study, the company has applied for marketing authorization in multiple procedures in general surgery within the upper abdomen.
“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.”
