强生OTTAVA手术机器人获FDA De Novo授权，进入Intuitive主导的美国软组织手术机器人市场

Johnson & Johnson (JNJ) on Wednesday announced the FDA authorization for its Ottava surgical robot, marking its entry into the U.S. robotic soft-tissue surgery market currently dominated by Intuitive Surgical (ISRG) and Medtronic (MDT).
In a statement before the market opened, the New Jersey-based healthcare giant said that the FDA granted its De Novo authorization for Ottava to perform soft-tissue-related surgical procedures such as appendectomy.
The platform, which has robotic arms integrated into the operating table itself, will be available for a select group of customers as part of its initial U.S. launch, the company said, adding that it plans to seek approval in other geographies and for other procedures in parallel.
An ongoing clinical trial in inguinal hernia procedures, one of the most common operations in the U.S., could lead to a second regulatory submission for Ottava early next year, Reuters reported, quoting TD Cowen analyst Michael Nedelcovych.
While J&J (JNJ) is not new to the robotic-assisted surgery market, with its robotic systems already available in the U.S. for procedures such as bronchoscopies, Ottava marked its entry into soft-tissue surgeries, which account for the most common surgical procedures.
Intuitive Surgical (ISRG) remains the leader in the soft-tissue surgery market with its da Vinci surgical system installed in more than 11,000 locations globally as of June 30.
In December, Medtronic (MDT) entered the market with the FDA nod for its Hugo robotic-assisted surgery system for prostatectomy and other urology procedures, which account for about 230K surgeries in the U.S. annually.
However, J.P. Morgan analyst Robbie Marcus expects Intuitive Surgical (ISRG) to retain its leadership given its first-mover advantage.
"While Ottava has some interesting selling points (smaller footprint), our doc checks continue to point to Intuitive as the clear favorite given its physician relationships and entrenched integration into the hospital workflow and academic programs," Marcus wrote.
Marcus opines that, like Medtronic (MDT), J&J (JNJ) could wait for FDA approval for Ottava in urology procedures before conducting a full commercial rollout.