Dive Brief:
- Johnson & Johnson said Wednesday it received Food and Drug Administration de novo authorization for its Ottava robotic surgery system to perform multiple procedures in general surgery.
- The authorization brings to the U.S. market a second heavyweight challenger to Intuitive’s da Vinci robot in soft tissue procedures, following Medtronic’s FDA clearance in late 2025. A wave of smaller companies, including CMR Surgical, Distalmotion and Moon Surgical, are also launching robotic systems in the U.S., giving Intuitive its first competition in more than two decades.
- J&J said it will launch Ottava with select U.S. customers while working to obtain additional indications and regulatory jurisdictions over time.
Dive Insight:
Ottava is the first soft tissue system to integrate robotic arms into the operating table. “We are pioneering a new category of surgical robotics with OTTAVA,” Tim Schmid, J&J’s worldwide chairman for medtech, said in a statement.
The FDA’s general surgery authorization covers Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, fundoplication, hiatal hernia repair and lysis of adhesions, a procedure to remove scar tissue. A U.S. clinical trial is also underway for Ottava in inguinal hernia repair.
Ottava takes up 30% to 50% less space than traditional boom- and cart-mounted systems and is designed to help hospitals and clinical teams improve surgical care while streamlining workflows to increase operating room efficiency, according to J&J. Synchronized table and robotic arm motions facilitate patient repositioning and multi-quadrant access to the anatomy. The system includes instrument innovations for commonly used surgical tools and connects to a digital platform for surgical data integration.
“Surgical robotics will play an increasingly important role in surgical care, but it’s clear that what defined the last 25 years of surgery will not define the next 25,” said Hani Abouhalka, J&J’s group chair of medtech surgery.
Stifel analyst Rick Wise noted the Ottava authorization comes well within J&J’s projected timeline of before year-end and just six months after the company filed its FDA submission, a relatively quick turnaround for de novo approvals.
Still, Wall Street analysts were skeptical of Ottava’s ability to gain ground on da Vinci, at least in the near term.
The robot’s launch “will almost certainly take a deliberate and phased approach, significant training (physicians and staff) will be required, and the indications for OTTAVA are still limited,” Wise wrote to clients. “But with this approval, [J&J] is now ‘in the game’ and can iterate and improve on OTTAVA over time, potentially building towards a system that is closer to directly competing with Intuitive’s broader offering.”
J.P. Morgan analyst Robbie Marcus said Ottava’s smaller footprint and unique bedside attachment are interesting selling points, but he expected Intuitive to see “very modest/immaterial” loss in market share over time.
“While OTTAVA does address certain real physician pain points,” Marcus wrote in a note, “we think it’s unlikely to materially dent Intuitive’s share.”
