FDA clears Johnson & Johnson OTTAVA robotic surgical system

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Johnson & Johnson announced that the U.S. Food and Drug Administration has granted De Novo authorization for the OTTAVA robotic surgical system, described as the first table-integrated soft tissue robotic system. The authorization covers multiple general surgery procedures such as Roux-en-Y gastric bypass, gastrectomy, cholecystectomy and others, and Johnson & Johnson plans a U.S. commercial launch with select customers while pursuing additional indications and jurisdictions. The system emphasizes a smaller OR footprint, automated table-integrated arms, new instruments, a connected Polyphonic digital ecosystem, and education support, while an inguinal hernia clinical trial is ongoing.

FDA granted De Novo authorization enabling U.S. commercial launch.