Johnson & Johnson Submits OTTAVA Robotic Surgical System to FDA for De Novo Classification
核心洞察
Johnson & Johnson has submitted its OTTAVA Robotic Surgical System (搜索) to the FDA for De Novo classification, targeting multiple upper abdominal procedures including gastric bypass (搜索) and hiatal hernia (搜索) repair.
The submission is supported by data from the company's first clinical trial completed at Memorial Hermann-Texas Medical Center (搜索), demonstrating the system's safety and effectiveness.
The OTTAVA system features a unique unified architecture and will connect to the Polyphonic digital ecosystem to address unmet surgical needs.
Johnson & Johnson announced on January 7, 2026, that it has submitted its OTTAVA Robotic Surgical System (搜索) to the U.S. Food and Drug Administration (FDA) for De Novo classification, marking a significant milestone in the company's surgical robotics development program. The submission targets marketing authorization for multiple procedures in general surgery within the upper abdomen.
Clinical Trial Data Supports Regulatory Submission
The De Novo classification request is based on data from the OTTAVA Investigational Device Exemption (IDE) study, which was designed to demonstrate the system's safety and effectiveness. The first cases in the clinical trial were completed in early 2025 at Memorial Hermann-Texas Medical Center (搜索) by Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston (搜索) and the lead study investigator.
"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 at 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."
System Design and Intended Applications
The OTTAVA system encompasses surgical instrumentation and will be connected to the Polyphonic digital ecosystem in the future. Given OTTAVA's novel architecture and differentiated technological capabilities, Johnson & Johnson filed for an indication covering multiple procedures in general surgery within the upper abdomen, including gastric bypass (搜索), gastric sleeve (搜索), small bowel resection, and hiatal hernia (搜索) repair.
"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 at Johnson & Johnson.
Expansion into Hernia Surgery
The company's development program extends beyond upper abdominal procedures. In late 2025, Johnson & Johnson received IDE approval to begin a U.S. clinical trial for OTTAVA in inguinal hernia (搜索) procedures, which represents one of the most commonly performed surgeries in the United States. This approval demonstrates the system's potential for broader surgical applications.
Multi-Specialty Platform Design
OTTAVA is designed as a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including complex surgeries that require a multi-quadrant approach. The system's unique unified architecture and surgical instrumentation are powered by Ethicon (搜索) expertise and are intended to address the unmet needs of surgeons and their teams.
The OTTAVA robotic system remains under development and is not currently authorized for marketing or sale in any market. The De Novo classification pathway is specifically designed for new, low-to-moderate-risk medical devices, making it an appropriate regulatory route for this innovative surgical platform.