J&J's Ottava Surgical Robot Gains FDA Approval for General Surgery Procedures

J&J is also counting on its deep presence in operating rooms as a major supplier of staplers and other surgical tools to make Ottava more appealing. Surgery is already the largest piece of J&J's medical technology, or MedTech, segment, and its importance will increase once the company sheds its slower-growing orthopedic business. MedTech is projected to account for roughly a third of J&J's sales this year, with the pharmaceutical segment, called Innovative Medicine, representing the rest.

"We're currently the global leader in surgery," Hani Abouhalka, the head of J&J's surgery and robotics unit, said in an interview with CNBC. "Our intention is to be a leader in surgical robotics."

Precedence Research projects the U.S. surgical robotics market will grow from roughly $4.4 billion in 2025 to $18.75 billion by 2035. Globally, Precedence expects the market to expand from $14.45 billion in 2026 to about $50.29 billion by 2035. Patient preferences for fewer and smaller incisions are largely driving the growth. UCSF Health, a major academic hospital in San Francisco, says less than a quarter of surgeries in the U.S. are currently performed robotically. Abouhalka said J&J believes Ottava can help "expand the market in the U.S."

Ottava's long-term success may not depend solely on persuading hospitals to move away from Intuitive, which pioneered the space more than two decades ago, or on beating other new entrants such as Medtronic, whose Hugo system was cleared by the FDA in December 2025. There could be multiple winners.

Some on Wall Street are skeptical about the role Ottava will ultimately play in robotic soft-tissue surgery. J&J has also been light on pricing and sales expectations, other than telling investors that it expects Ottava to be a material financial contributor within a few years.

J&J's history in surgery dates to 1886, when Robert Wood Johnson and his two brothers founded the company to develop and mass-produce sterile surgical products. At the time, infections after surgery were common and often fatal, and the science around germs and their role in infections was still in its early days. J&J's products helped the medical community apply its evolving understanding. In 1949, J&J formed Ethicon Suture Laboratories, now known as Ethicon and part of its MedTech division. Through the subsidiary, J&J expanded its line of surgical products. Today its surgery portfolio includes instrumentation, energy devices, stapling systems, wound closure, biosurgery products, and digital and robotic technologies used in hospitals and surgical centers worldwide.

Ethicon's extensive presence in operating rooms could give J&J a leg up as it introduces Ottava to surgeons and hospitals already familiar with its products. It may also create opportunities for J&J to bundle Ottava with other surgical tools, according to Dr. Jacob Greenberg, an associate professor of surgery at Duke University and a paid consultant for J&J.

"If your [hospital] system is a J & J system — meaning it uses Ethicon sutures and Ethicon staplers and Ethicon energy sources — I think they could probably provide some decrease in the cost of those if your system also takes on Ottava," Greenberg said. "They'll have opportunities to bundle together a lot of their product lines to drive implementation," he said.

J&J's surgery business generated $5.16 billion in revenue through the first six months of the year, up 4.3% year over year, or roughly 30% of total MedTech sales. MedTech's other main focuses going forward are cardiovascular and vision. The cardiovascular business includes Impella heart pumps, catheters to treat abnormal heart rhythms, and Shockwave Medical's devices used to break down calcium built up in arteries; J&J acquired Shockwave in May 2024. Vision sells consumer-facing Acuvue contact lenses.

Editor's Summary

Johnson & Johnson's Ottava surgical robot has received FDA approval for multiple general surgery procedures, entering a robotic soft-tissue market long led by Intuitive Surgical. J&J is leaning on its operating-room presence and product bundling while the market is projected to grow, though the company has not disclosed pricing or sales expectations.