Overview
- The FDA granted De Novo marketing authorization for Ottava, a decision reported Tuesday that clears Johnson & Johnson to begin a targeted U.S. commercial rollout.
- Ottava is authorized for multiple upper‑abdominal general surgery procedures including hernia repair, cholecystectomy, gastric bypass, appendectomy and splenectomy.
- The system’s robotic arms are built into the operating table, a design J&J says cuts operating‑room footprint by about 30–50% compared with boom‑ or cart‑mounted robots.
- J&J submitted Ottava in January after an investigational device exemption study and completed a roughly six‑month FDA review; the stock rose about 1.7% on the news and analysts reacted positively.
- The clearance positions J&J to challenge entrenched players such as Intuitive Surgical and Medtronic while potentially expanding robotic surgery into smaller hospital rooms in a market where adoption remains low.