OTTAVA receives US FDA De Novo authorization - 2026-07-22 - Regulatory - 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… - source: jnjmedtech.com
Johnson & Johnson submits OTTAVA robotic surgical system to FDA - 2026-01-07 - Regulatory - Johnson & Johnson MedTech submitted the OTTAVA robotic surgical system to the U.S. FDA. The submission was supported by data from the system's investigational device exemption study. The event marks a regulatory milestone after… - source: jnj.com
Johnson & Johnson MedTech completes first clinical cases with OTTAVA surgical robot - 2025-04-14 - Capability - Johnson & Johnson MedTech completed the first cases in the clinical trial for the OTTAVA robotic surgical system. The first procedure was a Roux-en-Y gastric bypass at Memorial Hermann-Texas Medical Center. The milestone moves… - source: jnj.com
Johnson & Johnson receives FDA IDE approval for OTTAVA robotic surgical system - 2024-11-13 - Regulatory - Johnson & Johnson MedTech received FDA investigational device exemption approval for OTTAVA. The approval allowed the company to begin a U.S. clinical trial of the robotic surgical system. The milestone preceded the first completed… - source: medthority.com