Johnson & Johnson Seeks FDA's De Novo Classification For OTTAVA Robotic Surgical System

(RTTNews) - Johnson & Johnson (JNJ), Wednesday announced the submission of an application to the U.S. Food and Drug Administration, seeking De Novo classification for OTTAVA Robotic Surgical System, a multi-specialty soft-tissue surgery robot.

Backed by the data from the Investigational Device Exemption study, the application aims to target 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.

Peter Schulam, Chief Scientific Officer, MedTech, commented, "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."

In the pre-market hours, JNJ is trading at $205.40, up 0.28 percent on the New York Stock Exchange.