Johnson & Johnson Submits OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration

Johnson & Johnson Submits OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Jan 7, 2026-

J&J submits FDA de novo request for Ottava robot in general surgery

Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft tissue robotic surgery market heats up.

OTTAVA Robotic Surgical System Submitted to FDA

New Brunswick, N.J. | Johnson & Johnson 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 …