Johnson & Johnson MedTech received FDA De Novo authorization for its OTTAVA Robotic Surgical System. The technology is the first robotic system integrated directly into an operating table.
The FDA cleared OTTAVA for soft tissue general surgery, including gastric bypass and gallbladder removal. This milestone marks the company's entry into the competitive robotic surgery market.
J&J plans a phased commercial launch for a select group of U.S. customers. The company is currently conducting a U.S. clinical trial for the system's use in inguinal hernia procedures.
The MedTech division will seek additional regulatory approvals in international markets. J&J also intends to expand the system’s cleared uses for further surgical procedures.