The U.S.
Food and Drug Administration on Wednesday granted De Novo authorization for Johnson & Johnson's (NYSE:JNJ) OTTAVA Robotic Surgical System, marking the regulatory clearance of the world's first table-integrated soft tissue robotic platform.
The marketing clearance encompasses multiple general surgery procedures.
The medical technology giant will initiate a commercial rollout with select U.S. facilities, prioritizing initial customer success while working to expand regulatory approvals and procedural indications globally.
An additional U.S. clinical study evaluating the platform for inguinal hernia procedures is currently underway.
