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A new era in surgery is coming

We are bringing over a century of experience working alongside surgeons to usher in the next era in surgery.

The future of robotic surgery will be more human, more adaptive and more connected.

We are developing a robotic surgical platform that will set a new standard for the modern OR and transform the surgical experience.

Designing in partnership

We're working together with surgeons, clinical teams, and hospitals to find ways to better serve patients through the promise of robotic surgery.

Focusing on the biggest challenges of today

of surgeons cite scheduling and access to the robot as a top barrier to performing more cases robotically.1

69%
Increasing availability and flexibility

By designing robotic surgery systems to better integrate into existing hospital systems and surgical workflows, technology can help enable greater access.

Lighten the load

As surgeons and surgical teams face the physical and mental pressures of surgery, new technologies can enable teams to work more comfortably, engage more seamlessly and move through the OR more easily.

of general surgeons suffer from symptoms of burnout.2

18%

of the world’s data is health data.3

15%
Activating the power of data

Connecting health data inside the OR and out can surface insights for surgical teams to support decision making when it matters most.

OTTAVA™

Johnson & Johnson Submits OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration

Data from Investigational Device Exemption (IDE) study in Roux-en-Y gastric bypass procedures used to support application for De Novo classification

Second IDE approved for U.S. clinical trial for OTTAVA in inguinal hernia procedures

January 7, 2026 — New Brunswick, New Jersey
Johnson & Johnson today 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.
View full press release
Ottava image one

“We believe the future of surgery is personal. Starting with the human impact – the connection between the patient, surgeon, and OR staff – we are unlocking what science and technology can do to improve the surgical experience and health outcomes for everyone involved. OTTAVA is designed to consistently deliver this experience in any OR globally.”

Hani Abouhalka Company
Group Chairman, Robotics & Digital

Ottava blue led

“The industry needs a system that is adaptable, easy to use in any OR in the world, and maintains space in the OR. As surgeons, we need space to improve the workflow in the OR, increase safety, and enable 360-degree patient access so we can perform at the capacity that we would like to. That’s where OTTAVA comes in. OTTAVA offers a unique design that incorporates into any OR and allows surgeons to do what they would like to do and know how to do, which is focus on the patient.”

Dr. Eduardo Parra-Davila
Colorectal and General Surgeon, Palm Beach Digital Surgery Institute

plastic curve medical device
Medical Device

The OTTAVA™ Robotic System is under development and is not authorized to be marketed or sold in any market.

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

1 Based on a September 2023 internally conducted survey of 146 surgeons worldwide with experience in robotic surgery.

1 Based on a September 2023 internally conducted survey of 146 surgeons worldwide with experience in robotic surgery.

2 Golisch, K. B., Sanders, J. M., Rzhetsky, A., & Tatebe, L. C. (2023). Addressing surgeon burnout through a multi-level approach: A National Call to Action. Current Trauma Reports, 9(2), 28–39.

3 The Healthcare Data Explosion Website. https://www.rbccm.com/en/gib/healthcare/episode/the_healthcare_data_explosion. Accessed October 24, 2023.

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