FDA authorizes Johnson & Johnson robotic system for ten surgical procedures
The FDA authorized Johnson & Johnson's OTTAVA robotic surgical system for ten general-surgery procedures, following the company's January 7, 2026 application. Johnson & Johnson plans to begin commercial sales with select U.S. customers.
Why it mattersPatients undergoing approved general surgeries in select American hospitals may receive care from this newly cleared robot.
How we got here
- Johnson & Johnson submitted the OTTAVA Robotic Surgical System to the FDA for De Novo classification. Jnjmedtech
- Johnson & Johnson announced results evaluating the OTTAVA system in Roux-en-Y gastric bypass procedures from its first clinical study. Jnj
- Johnson & Johnson announced the scheduling of its third-quarter results call. Jnj
- Johnson & Johnson announced new Phase 3 MajesTEC-3 analyses for TECVAYLI combined with DARZALEX FASPRO in treating multiple myeloma. Jnj
What's likely next
- Date not specified: Johnson & Johnson said it would commercially launch OTTAVA with select U.S. customers while working toward additional indications and regulatory jurisdictions.
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