Johnson & Johnson (NYSE:JNJ) today announced results from the first clinical study of its investigational Ottava surgical robot.
Study results, presented at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting, mark the latest milestone for Ottava, following the company’s submission of the robot to the FDA for de novo approval in January.
The company first shared details about Ottava in 2020 as a potential minimally invasive surgical robotic option to rival longtime soft-tissue robotics leader Intuitive Surgical. Ottava is one of several long-awaited entries to the surgical robotic market, including Medtronic’s Hugo, which earned its first FDA nod for urologic procedures in December 2025.
After the initial unveiling, the company remained quiet about Ottava before it pushed back the platform’s development timeline by about two years due to multiple factors in late 2021.
In October 2024, the company announced that it submitted Ottava for IDE. Less than a month later, the FDA approved that IDE, enabling J&J to initiate this study of the surgical robot. The company reported the first completed cases with Ottava in April of this year.
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Now, J&J has clinical findings for the robotic platform in Roux-en-Y gastric bypass procedures in the FORTE study. In a 30-patient cohort, Ottava met its primary safety and performance endpoints through 30-days post-procedure. Investigators completed all procedures robotically on Ottava without conversion to a non-robotic approach.
Average weight loss by 30 days came in at 30 pounds. J&J said it used the findings, with preclinical testing, to support its FDA submission. It targets an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
Ottava incorporates four robotic arms into a standard-size surgical table. Its unified architecture allows for an invisible design, J&J says. The robotic arms are available when needed and stowed beneath the surgical table when not. In this study, Ottava was successfully installed and used across operating rooms in six participating hospitals. Those operating rooms ranged in size from 243 sq. ft to 694 sq. ft.
At five of six sites, procedures took place in operating rooms not previously used for robotic surgery. The company said these rooms were historically considered “challenging” for robotic systems due to space constraints.
According to the company, Ottava’s unique architecture, Ethicon instrumentation, and future integration with the Polyphonic digital ecosystem could address the unmet needs of surgeons and their teams.
Commentary from Johnson & Johnson officials and investigators
Hani Abouhalka, company group chair, Surgery, MedTech, Johnson & Johnson, said:
“This is an exciting milestone for our program as we share the role of Ottava as a robotic surgical system with a novel architecture supporting patient treatment during the clinical trial. This work also underscores our long-term commitment to bariatric surgeons and to equipping clinicians with a broad portfolio of surgical technologies to address the complexity of obesity care. Across open, laparoscopic, and robotic surgery, we remain focused on translating innovation into real-world solutions that help surgeons broaden access to precision surgical care and improve outcomes for patients.”
Dr. Peter Schulam, chief scientific officer, MedTech, Johnson & Johnson
“Our progress with Ottava relies on rigorous preclinical work, disciplined data collection in the clinic, and tight collaboration with the surgeons who use it – especially the investigators in the FORTE clinical study. These results further illustrate how novel architecture supports a differentiated approach where it matters most: in real operating rooms, with real patients. At each step – from bench to preclinical and now human trial – we have observed that this system can allow more hospital ORs to accommodate robotics. These results demonstrate that the novel architecture can integrate into existing infrastructure and remove practical barriers to broader adoption.”
Dr. Erik Wilson, chief of minimally invasive and elective general surgery at UTHealth Houston, director of bariatric surgery at Memorial Hermann-Texas Medical Center, and lead investigator for the clinical study, said:
“The data show encouraging evidence regarding the safety and performance of the Ottava robotic surgical system in Roux-en-Y gastric bypass procedures. Continued innovation in bariatric surgery is important to patient care, and I am pleased to present these initial clinical results.”
