Johnson & Johnson has announced the submission of its OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration (FDA), marking a key regulatory milestone for the company’s surgical robotics program.
According to the press release (Jan 7, 2026), the submission is based on data from an Investigational Device Exemption (IDE) clinical study and seeks De Novo classification. OTTAVA is designed for soft-tissue surgical procedures, with an initial focus on general surgery, and features a four-arm robotic system integrated into the operating table, aiming to optimize workflow and space within the operating room.
Johnson & Johnson positions OTTAVA as part of a broader digital surgery ecosystem, intended to connect robotic technology with data, instrumentation, and surgical insight. While the system is not yet cleared for commercial use, this FDA submission represents a significant step toward clinical availability.
A detailed overview of the OTTAVA Robotic Surgical System—including its design, development, and future implications—is available here.
J Granell. Jan 8, 2026