FDA Grants De Novo Authorization for Johnson & Johnson OTTAVA™ Robotic Surgical System
The FDA has officially authorized the Johnson & Johnson OTTAVA™ Robotic Surgical System under the De Novo pathway, enabling market availability in the U.S. This table-integrated soft-tissue robotic system is expected to provide enhanced capabilities to surgical teams, promoting improved precision in operations. The announcement was made by Johnson ...
- Published date: 19-08-2026 10:03 AM
The U.S. Food and Drug Administration has granted De Novo market authorization for Johnson & Johnson's OTTAVA™ Robotic Surgical System. This regulatory clearance marks a significant milestone for the advancement of robotic surgical technologies in the United States.
The OTTAVA™ system is a table-integrated soft-tissue robotic platform designed to enhance precision and control in surgical procedures. Its innovative design aims to support surgeons and surgical teams in delivering improved patient outcomes.
This authorization, announced on July 22, 2026, by Johnson & Johnson, represents a commitment to advancing surgical care through cutting-edge technology. Hospital administrators and surgical professionals are encouraged to consider the potential clinical applications of the OTTAVA™ system in various surgical settings.