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SurgiBot Sunk? TransEnterix Turns To Alternative Robot System After FDA Denial

The company plans to reduce headcount and investment focused on its SurgiBot laparoscopic robotic surgery system, recognizing that it does not have the resources to put together a new 510(k) and, at the time, prepare a recently acquired system for FDA submission.

TransEnterix Inc. says it is going to prioritize commercialization of its ALF-X robotic surgery system and take resources away from supporting the SurgiBot system now that it has determined that the SurgiBot will likely require a whole new submission to the FDA to give it any chance of ever reaching the US market.

In April, the FDA notified TransEnterix that SurgiBot, a single-port robotically enhanced laparoscopic surgery platform, does not meet the criteria for substantial equivalence in response to a

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