Dive Brief:

• The first cases using Johnson & Johnson’s Ottava surgical robot have been completed in its clinical trial, the company said Monday. The gastric bypass surgeries mark a milestone in the soft tissue system’s journey to market.
• J&J encountered delays in its effort to develop a soft tissue robot to compete with market leader Intuitive Surgical’s da Vinci, pushing out the U.S. approval timeline. But now, after gaining an investigational device exemption in November for the U.S. clinical trial, the company is progressing toward a de novo submission to the Food and Drug Administration for Ottava. A spokesperson declined to provide details on the expected timing of the submission.
• J&J plans to request an indication spanning multiple procedures in general surgery within the upper abdomen, including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair. 

Dive Insight:

Ottava is a key product in the healthcare giant’s pipeline, as robotic systems are increasingly used across a variety of surgical specialties. J&J’s robot has four arms built into the operating table that can be stored below to free up space for clinical teams.

“Surgical robotics is at the forefront of innovation in minimally invasive surgery,” Erik Wilson, chief of minimally invasive and elective general surgery at UT Health Houston, said in J&J’s statement. Wilson, the study’s lead investigator and a paid J&J consultant, said he hoped to advance the standard in surgical robotics.

J&J already sells the Monarch robotic lung biopsy platform and the Velys robot for orthopedic applications.

With Ottava, J&J is targeting Intuitive’s stronghold in robotic general surgery, where Medtronic also aims to compete, and smaller companies such as CMR Surgical and Moon Surgical have a head start with U.S. authorizations in hand.

Medtronic in February said it was on track to file in March for FDA approval for its Hugo robot with urology indications. The company said it was targeting a U.S. launch of Hugo in its fiscal year 2026, which begins in late April, and is studying the robot in hernia and benign gynecology procedures.

Ottava is designed to support a range of soft tissue procedures and specialties, J&J said, including complex surgeries. The robot incorporates J&J Ethicon surgical instruments and a digital system called Polyphonic to connect surgical technologies, robotics and software to support clinical decision making.