(NYSE: JNJ)
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announced today that it submitted its Ottava surgical robotic system to the FDA for de novo approval.
The company said it used data from an FDA investigational device exemption (IDE) study to support the submission. It initiated this study of the surgical robot in late 2024. Johnson & Johnson MedTech’s submission covers multiple procedures in general surgery within the upper abdomen.
Submission to the FDA marks the latest step forward for J&J MedTech and Ottava, following the system’s unveiling in fall 2021. The company debuted Ottava as a potential minimally invasive surgical robotic option to rival longtime soft tissue robotics leader Intuitive Surgical. It’s one of a handful of long-awaited entries to the surgical robotic market, including Medtronic’s Hugo, which just last month earned its first FDA nod for urologic procedures.
“We have taken learnings from Johnson & Johnson’s 140 years in surgery, our decades of leadership in minimally invasive surgery, and the experiences robotic surgeons and hospitals have had over the past 20 years to design a soft tissue robotic system built for the future of surgery,” said Hani Abouhalka, company group chair, Surgery, Johnson & Johnson MedTech. “I am proud of the design decisions and major scientific efforts that have gone into the system to support surgeons and successfully complete our first clinical trial, and I look forward to reaching the next milestone on our path to commercialization.”
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More about the Ottava surgical robot
Johnson & Johnson first shared details on the Ottava surgical robotic platform in November 2020. The company hoped to enter the soft-tissue robotics space, long dominated by Intuitive Surgical.
However, after that initial unveiling, the company remained quiet on the topic for the most part. In October 2021, it pushed back the platform’s development timeline by about two years due to multiple factors.
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.
The initial unveiling of Ottava highlighted a six-armed approach for the robot. In late 2023, the company shed more light on Ottava and some changes in its look over the time that had passed. The company said 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.
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.
More from Johnson & Johnson MedTech on the FDA submission and future applications
According to Johnson & Johnson MedTech, Dr. Erik Wilson completed the first cases in the OTTAVA IDE study in early 2025. The procedures took place at the Memorial Hermann-Texas Medical Center.
J&J MedTech said the study’s data from the completed trial aimed to showcase safety and effectiveness in a variety of procedures. The de novo request covers multiple procedures in general surgery within the upper abdomen. Those include gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.
“The IDE study builds on a significant body of preclinical evidence we have generated demonstrating the impact of the OTTAVA system and provides critical clinical evidence on the system performance,” said Dr. Peter Schulam, chief scientific officer, Johnson & Johnson MedTech. “Surgeon investigators across several hospitals led this important study to further clinical evidence in support of minimally invasive, robotic-assisted surgery for the benefit of clinical teams, hospitals, and patients.”
The medtech giant also has a second clinical trial set to evaluate hernia repair, with the FDA approving an IDE for that study in late 2025.