Friday, March 04, 2022 4:29:32 PM
Who would have thunk? RBOT-vicarious
We had previously communicated our intent to file a 510(k) application for the Vicarious System for ventral hernia procedures by late 2023. We now expect to file a De Novo classification request by late 2024. While this development delays our initial submission timeline, we expect a more muted Impact on the long-term roadmap, considering our original timeline for market assumed a post-approval clinical trial process prior to broad commercialization.
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