Johnson & Johnson Submits OTTAVA Robotic Surgical System for FDA De Novo Review
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Johnson & Johnson has submitted its OTTAVA™ Robotic Surgical System to the FDA for De Novo classification, seeking marketing authorization for various upper abdomen surgeries. This submission is backed by data from a clinical trial at Memorial Hermann-Texas Medical Center. Additionally, the company received IDE approval to start a U.S. clinical trial for inguinal hernia procedures. The OTTAVA system is a multi-specialty soft-tissue surgery robot currently awaiting regulatory approval.
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