Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

FDA Not Impressed With TransEnterix's SurgiBot 510(k)

This article was originally published in The Gray Sheet

Executive Summary

The company seeking to make waves in the robotic surgery space hit a major speed bump with a finding by FDA that its SurgiBot did not meet substantial equivalence requirements.