Johnson & Johnson Announces First Clinical Results for Ottava Robotic Surgical System and Submits De Novo FDA Application

Source:Medical Device Frontline

Recently, Johnson & Johnson released its Ottava surgical system under development.RobotFirst Clinical Research Achievement:In 30 cases of Roux-en-Y gastric bypass surgery, the system achieved excellent results with zero severe complications and zero conversions to open surgery within 30 days post-operation. Patients experienced an average weight loss of 30 pounds, successfully meeting both safety and efficacy endpoints.

Industry analysis believes that this breakthrough marks Johnson & Johnson's formal challenge to the surgical robot market dominated by Intuitive Surgical, bringing an opportunity for restructuring the competitive landscape of the industry.

Ottava Robot Clinical Research Results Are Impressive

As the core product of Johnson & Johnson's layout in the field of minimally invasive surgery, the Ottava robotSince its initial disclosure in 2020, after several rounds of research and development adjustments, an Investigational Device Exemption (IDE) application was submitted in October 2024. The FDA approval was obtained the following month, allowing for the swift initiation of clinical trials, with the first batch of surgical cases completed this past April.R&D progress accelerates.

The FORTE study was conducted in six hospitals, covering operating rooms of different specifications. Five of these were "space-constrained" operating rooms where robotic surgeries had not been previously performed, validating Ottava's environmental adaptability.

Ottava's core competitiveness stems from innovative architectural design,It integrates four robotic arms into a standard operating table, retracting them under the table when not in use to achieve an "invisible" layout.This design solves the industry pain point of traditional robots occupying too much space.

Hani Abouhalka, President of Johnson & Johnson Medical Technology Surgical Business, stated,This architecture is compatible with existing hospital infrastructure, allowing more medical institutions to conduct robotic surgeries without the need for renovation, effectively lowering the threshold for technology adoption.In cooperation with Ethicon, a professional surgical instrument brand under Johnson & Johnson, the system will also be integrated into the Polyphonic digital ecosystem in the future, further enhancing the precision of surgeries.

The Pattern of the Surgical Robot Market is Changing

Ottava Has Differentiated Advantages

This clinical breakthrough comes at the peak of the global surgical robot market boom. According to Precedence Research, the global market size is expected to reach $14.45 billion by 2026, with an annual compound growth rate as high as 14.95%, of which laparoscopic surgical robots account for more than 60%.

For a long time, Intuitive Surgical's Da Vinci system has monopolized the market with over 60% market share, butThe rise of new forces such as Medtronic's Hugo and Johnson & Johnson's Ottava is breaking this pattern.In December 2025, Medtronic Hugo received FDA approval for urological indications.Ottava, on the other hand, focuses on general surgery of the upper abdomen, targeting high-frequency surgical scenarios such as gastric bypass and sleeve gastrectomy to form differentiated competition.

Peter Schulam, Chief Scientific Officer of Johnson & Johnson Medical Technologies, emphasized that the development of Ottava has always been driven by clinical needs. "From the laboratory to the operating room, we have validated the value of innovative architecture in real clinical scenarios through in-depth collaboration with surgeons."

Erik Wilson, Ph.D., Chief Researcher of the study and from the University of Houston Health Science Center, added that technological innovations in bariatric surgery are directly related to patients' quality of life, and Ottava's preliminary data provides the industry with a new technical option.

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Currently, Johnson & Johnson has based on clinical data and preclinical studies,Submit a new classification marketing application for Ottava to the FDA, intended to cover multiple upper abdominal surgical indications such as gastric bypass, small bowel resection, and hiatal hernia repair.As the approval process advances, Ottava is expected to become the first robotic system to simultaneously meet the needs of compact operating rooms and multi-procedural demands, filling a market gap.

Industry analysis points out that, against the backdrop of a continuously increasing global penetration rate of minimally invasive surgeries, the combination of Ottava's differentiated positioning and Johnson & Johnson's channel advantages is expected to capture 10%-15% of the market share within the next three years, driving the surgical robotics industry to transition from high-end niche applications towards inclusive healthcare.