Johnson & Johnson announced that it has gone ahead and submitted its Ottava surgical robotic system to the FDA for a de novo approval.
The company confirmed that it made use of data from the FDA investigational device exemption – IDE study in order to support the submission. It went on to initiate this study of the surgical robot in late 2024. MedTech’s submission by Johnson & Johnson goes on to cover numerous procedures in general surgery when it comes to the upper abdomen.
It is well to be noted that the submission to the FDA goes on to mark the latest step forward when it comes to J&J MedTech as well as Ottava, after the unveiling of the system in the fall of 2021. The company went on to debut Ottava surgical robotic system as being a potentially minimally invasive surgical robotic alternative to Intuitive Surgical, the longtime rival and soft tissue robotics leader.
It is one of a handful of the long-awaited entries to the surgical robotic market that includes Hugo from Medtronic, which in December 2025 went on to earn its first-ever FDA approval in terms of urologic procedures.
According to the company group chair for Surgery, Johnson & Johnson MedTech, Hani Abouhalka, they have taken learnings from Johnson & Johnson’s 140 years in surgery and their decades of leadership when it comes to minimally invasive surgery, along with the experiences robotic surgeons as well as hospitals have had in the past 20 years, to go ahead and design a soft tissue robotic system that is built for the future of surgery. He added that he is proud of the design decisions and also the major scientific push that has gone into the system in order to support the surgeons and also successfully complete their first clinical trial, and that he looks forward to reaching the upcoming milestone in their path to commercialization.
Johnson & Johnson first went ahead and shared details on the Ottava surgical robotic platform on November 20.
The company back then had hoped to enter the soft-tissue robotics spectrum that’s long been dominated by Intuitive Surgical. But, after that initial unveiling, the company went quiet on the topic for the most part. In October 2021, it went ahead and pushed back the development timeline of the platform by around 2 years because of many factors.
In October 2024, the company went on to announce that it had submitted Ottava for IDE, and less than a month later, FDA went on to approve that IDE, thereby helping J&J to start this study on surgical robots.
It is well to be noted that the initial unveiling of Ottava underscored a six-armed approach for the robot. In late 2023, the company shed some more light on Ottava and also some alterations in its look with the time that had passed. The company remarked that Ottava had gone ahead and incorporated four robotic arms in a standard-size surgical table. Its unified architecture enables invisible design, shares J&J.
The robotic arms are available when required and stowed beneath the surgical table when they are not needed.
The company says that the unique architecture of Ottava, Ethicon instrumentation, and also future integration along with the Polyphonic digital ecosystem could address unmet needs of the surgeons as well as their teams.
Johnson & Johnson MedTech’s Dr. Erik Wilson went on to complete the first cases in the OTTAVA IDE study in early 2025. The procedures went on to take place at the Memorial Hermann-Texas Medical Center.
J&J MedTech said that the data from the completed trial of the study aimed to demonstrate safety as well as effectiveness in an array of procedures. The de novo request goes on to cover numerous procedures in general surgery in the upper abdomen. Those go on to include gastric bypass, small bowel resection, gastric sleeve as well as hiatal hernia repair.
Dr. Peter Schulam, the chief scientific officer from Johnson & Johnson MedTech, says that the IDE study goes on to build on a significant body of certain preclinical evidence they have generated showcasing the impact of the OTTAVA system and offers critical clinical evidence on its performance. He adds that the Surgeon investigators throughout several hospitals led this significant study to more clinical evidence in support of the minimally invasive and robotic-assisted surgery for benefit of clinical teams, hospitals as well as patients.
The medtech giant also happens to have a second clinical trial that is set to assess hernia repair, with the FDA going ahead and approving an IDE for that study in late 2025.