Corrections
This article was originally published in The Gray Sheet
Executive Summary
Stories referencing Neuronetics in the Jan. 5 (1p. 24) and Oct. 13 (2p. 6) issues of "The Gray Sheet" inaccurately suggested that the firm's NeuroStar transcranial magnetic stimulation system was 510(k)-cleared as substantially equivalent to a predicate device. NeuroStar was 3allowed on the market Oct. 7, 2008, via the de novo, or "evaluation of automatic class III designation," 4process, under which FDA found sufficient information to place the device into class II, special controls, after the product was deemed not substantially equivalent due to lack of a predicate