FDA clears Johnson & Johnson OTTAVA robotic surgical system
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.
Context
The FDA granted De Novo authorization for OTTAVA in the U.S. This allowed Johnson & Johnson to begin a limited commercial launch and pursue more approvals and indications.
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