Johnson & Johnson announced that it has filed a De Novo application with the U.S. Food and Drug Administration for its OTTAVA™ Robotic Surgical System, a platform designed for upper‑abdominal general‑surgery procedures. The filing, dated January 7, 2026, marks the first formal step toward marketing approval for the system.
The submission incorporates data from a recent investigational device exemption (IDE) study that demonstrated the system’s safety and efficacy across a range of surgical applications. By pursuing a De Novo pathway, J&J seeks to establish a regulatory foothold for a novel device that has no predicate clearance, positioning the company to capture a share of the growing robotic‑surgery market.
OTTAVA represents a strategic expansion of J&J’s MedTech portfolio into a high‑margin, high‑growth segment. The company has been investing heavily in surgical robotics, and the new system is intended to compete with established players such as Intuitive Surgical’s da Vinci platform. Successful approval would add a new revenue stream that could help offset pressure on legacy medical‑device lines.
The move aligns with J&J’s broader strategy to strengthen its MedTech business, which has historically delivered robust margins and steady growth. By adding a robotic‑surgery platform, the company aims to diversify its product mix and tap into the projected multi‑billion‑dollar global market for minimally invasive surgical solutions.
While the FDA review timeline remains uncertain, the submission signals J&J’s commitment to innovation in surgical technology and its intent to become a more prominent player in the competitive robotics arena.
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