FDA approves Johnson & Johnson's Ottava robotic system for multiple soft-tissue surgeries

FDA cleared Johnson & Johnson's Ottava robotic surgical system, marking its entry into the market.

The clearance covers a range of soft-tissue procedures such as gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, adhesiolysis, fundoplication and hiatal hernia repair.

J&J said it will launch the system with select U.S. customers, focusing on early success while pursuing additional indications like inguinal hernia and expanding to other regulatory regions.

The robot is designed to fit standard operating rooms with four arms integrated into a regular surgical table, eliminating the need for a separate boom.