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

Key Terms

investigational device exemption (ide) regulatory

An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.

de novo classification regulatory

A de novo classification is a regulatory pathway that lets a novel medical device without an existing equivalent be reviewed and approved as low-to-moderate risk so it can legally enter the market. For investors, it matters because it can unlock a faster, clearer route to sales and competition protection for a new product — like getting a brand-new grocery item its own shelf space rather than forcing it to fit an existing category.

gastric bypass medical

Gastric bypass is a surgical procedure that reduces stomach size and reroutes part of the small intestine so food bypasses a portion of the digestive tract, leading to reduced calorie absorption and quicker fullness. For investors, it matters because the procedure drives demand for medical devices, hospital services, pharmaceuticals, and follow-up care; outcomes and complication rates can affect healthcare costs, reimbursement, and the revenue prospects of companies in the weight-management and surgical sectors.

inguinal hernia medical

An inguinal hernia is when tissue, often part of the intestine, pushes through a weak spot in the lower abdominal wall near the groin, producing a visible bulge and sometimes pain or discomfort. For investors, it matters because it drives demand for surgical repairs, medical devices and related drugs, and can affect healthcare costs, procedure volumes and regulatory or reimbursement decisions—much like a recurring leak that signals ongoing repair and equipment needs in a building.

robotic-assisted surgery medical

Robotic-assisted surgery uses a surgeon-controlled robotic system to perform or assist with operations, where the doctor operates instruments through small incisions while a machine translates their movements into precise actions. For investors, it matters because these systems change procedure costs, hospital purchasing and training needs, and recurring revenue from instruments and service contracts—similar to how a new industrial robot can reshape manufacturing costs and output.

multi-quadrant approach technical

A multi-quadrant approach is a strategy that pursues several distinct business areas, customer groups, geographic markets or product categories at the same time, rather than focusing on just one. For investors it signals diversification of revenue sources and potential for broader growth, but also implies greater complexity and resource needs—like running multiple shops in different neighborhoods instead of a single flagship store.

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

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- 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.

“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. For more information, visit: http://thenext.jnjmedtech.com/surgical-robotics.

About Surgical Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. For over 100 years, we have helped advance surgical care through our innovative portfolio across wound clossure, adjunctive hemostats, surgical stapling and instruments, robotics and digital solutions. Together, with clinicians and healthcare experts around the world we are progressing what’s next in surgery to better solve patient needs in metabolic and cardiovascular disease, cancer, and aesthetics and reconstruction. For more, visit https://thenext.jnjmedtech.com.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.

Cautions Concerning Forward-Looking Statements
The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

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

¹ IQVIA Hospital Procedure Data Set, 2023 actuals

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Media contact:

Lindsey Diaz-MacInnis

LDiazMac@ITS.JNJ.com

Source: Johnson & Johnson