Johnson & Johnson Submits De Novo Application to FDA for OTTAVA Soft Tissue Robotic Surgery System

Jan 07, 2026 22:10 CST Updated 22:10

Johnson & Johnson

Medical Device R&D and Manufacturer

Medtronic

Medical Device Manufacturer

Intuitive

Surgical Robot Developer

Johnson & Johnson Announces Submission of Soft Tissue Surgical Robot to FDAOTTAVADe Novo Application. Based on Investigational Device Exemption (IDE) study data, Johnson & Johnson is seekingOTTAVAMarketing authorization for various surgeries in the upper abdomen general surgery.

Executive Evaluation

"We have drawn on Johnson & Johnson's 140 years of surgical experience, decades of leadership in minimally invasive surgery, and the practical wisdom of robotic surgeons and hospitals over the past 20 years to design this future-oriented soft tissue surgical robot system," Qiang stated. "I am proud of the team's dedication to the system's design decisions and significant scientific research investment, which successfully supported the completion of our first clinical trial. I look forward to achieving the next milestone on the path to commercialization."

---Hani Abouhalka Johnson & JohnsonChairman of the Surgical Business Group, Medtronic

This Johnson & JohnsonDe Novo Application, Based on Johnson & Johnson's IDE Clinical Study Conducted Last Year (This StudyIndications cover multiple upper abdominal general surgeries, such as gastric bypass, sleeve gastrectomy, small bowel resection, and hiatal hernia repair.) andOTTAVAInnovative Architecture and Differentiated Technical Capabilities。This TimeThe goal of the De Novo application is also toOTTAVAIndications can coverVarious upper abdominal general surgeries, such as gastric bypass, sleeve gastrectomy, small bowel resection, and hiatal hernia repair.

This indication is much broader compared to the indication approved last year for Medtronic's Hugo (which is currently only used in urological surgeries).

Executive Evaluation

"This IDE study builds on extensive preclinical evidence validating the value of OTTAVA and provides crucial clinical evidence for system performance. Surgical experts from multiple hospitals led this significant research, further accumulating clinical evidence supporting minimally invasive robot-assisted surgery, ultimately benefiting clinical teams, hospitals, and patients."

---Peter Schulam Chief Scientific Officer of Johnson & Johnson Medical Technology

Currently, the FDA has approved the market entry of soft tissue surgical robots from multiple companies, but the one with the largest market share remainsIntuitivThe da Vinci series by Intuitive, followed by the market-favored Medtronic Hugo. However, Hugo andOTTAVAAbout the same, the progress of the two companies is actually not much different, mainly it still depends onIntuitivThe da Vinci series by Intuitive.Intuitive with the da Vinci seriesHas already begun to shake the surgical foundations of Johnson & Johnson and Medtronic, including products like endoscopic staplers, large vessel sealers, and ultrasonic scalpels.Intuitive-market share is getting higher and higher. Among themThe market share of cavity mirror staplers in the United States even exceeds the total of Johnson & Johnson and Medtronic, so both Johnson & Johnson and Medtronic continue to develop their own soft tissue surgical robots to stabilize their market share.

Like Johnson & Johnson, in addition to actively developingOTTAVAIn addition, it has continuously invested in other companies' soft tissue surgical robots, such as investing in China's Rui Long Surgical last year. Of course, investing in soft tissue surgical robot companies cannot solve the real problem for the leading surgical company; it still needs its own soft tissue surgical robot. Now submittedOTTAVA De Novo Application, Awaiting FDA Import Approval for Market Launch. Effectively Blocking...Intuitive, reverse the declining trend.

Ottava

OttavaA surgical robot with four mechanical arms is able toFour robotic arms are integrated into a standard-sized operating table.This kind of invisible structural design allows the robotic arm to be fixed on the operating table when needed, and stored under the operating table when not in use.The design eliminates mobility and collaboration barriers in robotic operating rooms, providing surgical teams with the freedom and flexibility to adapt to clinical workflows and personalized patient needs.

OttavaInvisible ArchitectureDesignSimilar toCMR SurgicalTheVersius。OttavaAdopting a zero-footprint design to increase operating room space and improve operating room workflow.OttavaThe robotic arm can be taken out and fixed on the operating table when needed, and removed when not in use.Stored under the operating table during the procedure.

OttavaThe "dual-motion" function – the unified movement of the operating table and robotic arm – is designed to meet critical clinical needs for the surgical team during procedures, such as the ability to reposition the patient without interrupting the surgery.

OTTAVA will also be integrated into the Polyphonic digital ecosystem in the future, aiming to meet the unmet clinical needs of surgeons and their teams.

Johnson & Johnson

Johnson & Johnson has always been committed to addressing the world's most complex health challenges. For a century, we have advanced surgical care through innovative products such as wound closure, hemostasis assistance, surgical stapling devices, robotics, and digital solutions. Collaborating with global clinical experts, we continuously revolutionize surgical techniques to better meet patient needs in metabolic diseases, cardiovascular diseases, oncology, and plastic reconstruction.