Johnson & Johnson Seeks FDA Approval for Ottava Surgical Robot as Competition Intensifies

Johnson & Johnson MedTech has submitted its Ottava soft tissue robotic surgery system to the U.S. Food and Drug Administration for de novo classification, signaling its formal entry into an increasingly competitive robotic surgery market. The filing comes roughly a month after Medtronic secured U.S. clearance for its Hugo system, underscoring growing rivalry in robot-assisted soft tissue procedures.

J&J said the FDA application seeks authorization for multiple general surgery procedures in the upper abdomen, including gastric bypass and gastric sleeve operations. The submission is backed by data from an investigational device exemption study in Roux-en-Y gastric bypass surgery. The company also received IDE approval in late 2025 to launch a U.S. clinical trial evaluating Ottava in inguinal hernia repair.

With Ottava, J&J aims to challenge Intuitive Surgical’s long-standing dominance. Analysts note the system’s integrated table motion and multi-quadrant capabilities as key differentiators, reflecting J&J’s confidence in the platform’s readiness for market entry.

11-01-2026