April 29, 2016
Name of Company: TransEnterix
SurgiBot and Alf-X: The North Carolina company got a rude shock in mid April when FDA rejected its SurgiBot robot deeming it to be not substantially equivalent to a predicate device. Its fate is unknown at this time.
However, TransEnterix has a second robot - the ALF-X system that it got through an acquisition. That device has the CE Mark and is planned to be introduced in the U.S. next year.
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