Johnson & Johnson has secured U.S. Food and Drug Administration (FDA) marketing authorization for its OTTAVA robotic surgical system, allowing the company to enter the U.S. soft-tissue robotic surgery market and begin a phased commercial rollout.
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Johnson & Johnson has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its OTTAVA robotic surgical system, marking the company’s entry into the U.S. market for soft-tissue robotic-assisted surgery. The authorization was announced on July 22 and represents a significant milestone for the healthcare company’s medical technology business.
The FDA has cleared the system for use in a range of upper abdominal general surgery procedures. These include Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve surgery, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.
Johnson & Johnson said the initial commercial launch of OTTAVA will begin with a limited group of U.S. healthcare customers. The company also plans to pursue additional regulatory approvals and expand the system into more surgical indications over time. A U.S. clinical trial evaluating the platform for inguinal hernia procedures is currently underway.
OTTAVA is designed with robotic arms integrated directly into the operating table rather than mounted on separate carts or booms. According to the company, this configuration reduces the system’s operating room footprint by approximately 30% to 50%, potentially making robotic-assisted surgery feasible in hospitals with more limited operating room space.
The authorization positions Johnson & Johnson to compete in a market currently led by Intuitive Surgical’s da Vinci platform, while also joining Medtronic, whose Hugo robotic surgery system entered the U.S. market after receiving FDA authorization last year. Industry analysts noted that although OTTAVA’s compact design could differentiate it from existing systems, the company faces competition from well-established platforms with broad hospital adoption.
The approval follows several years of development for the OTTAVA platform and marks the beginning of Johnson & Johnson’s commercial expansion in robotic-assisted surgery, an area expected to remain a key focus for the company’s MedTech business.
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