OTTAVA receives US FDA De Novo authorization
Johnson & Johnson received US FDA De Novo marketing authorization for the OTTAVA Robotic Surgical System.
Evidence notes
- Authorization covers multiple upper-abdominal general-surgery procedures.
- OTTAVA coordinates four table-integrated robotic arms with synchronized table motion.
- A 30-patient pivotal gastric-bypass study completed every procedure robotically without conversion.
Company context
Johnson & Johnson is a global healthcare company with surgical robotics exposure through OTTAVA and Monarch within its medtech business.