Johnson & Johnson Submits OTTAVA™ Robotic Surgical System to the U.S. FDA

Johnson & Johnson has announced that the company has submitted the OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration (FDA) in an application for De Novo classification. Leveraging data from the Investigational Device Exemption (IDE) study, the company has applied for marketing authorization in multiple procedures in general surgery within the upper abdomen.

“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, MedTech, Johnson & Johnson. “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.”

Data from first clinical trial supporting submission

First cases in the OTTAVA IDE study were completed in early 2025 at Memorial Hermann-Texas Medical Center by Dr. Erik Wilson*, Chief of Minimally Invasive and Elective General Surgery UT Health Houston and the lead investigator for the clinical study.

OTTAVA’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and future connection to the Polyphonic™ digital ecosystem are designed to address the unmet needs of surgeons and their teams. The Company filed data from the completed clinical trial with the aim of showcasing safety and effectiveness and supporting the system’s ability to perform a variety of procedures. Given OTTAVA’s novel architecture and differentiated technological capabilities, the company filed a De Novo classification request and is targeting 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.

“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 Peter Schulam, M.D., Ph.D., Chief Scientific Officer, MedTech, Johnson & Johnson. “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.”

Second clinical trial approved in hernia repair

OTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach. In late 2025, Johnson & Johnson received IDE approval to begin a U.S. clinical trial for OTTAVA in inguinal hernia procedures, one of the most common surgeries in the U.S.¹

The OTTAVA robotic system is under development and is not authorized to be marketed or sold in any market.

Footnotes
*Dr. Wilson is a paid consultant for Johnson & Johnson MedTech.

¹ IQVIA Hospital Procedure Data Set, 2023 actuals

Source: Johnson & Johnson

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