SpectRx' BiliCheck
This article was originally published in The Gray Sheet
Executive Summary
510(k) is filed for the non-invasive bilirubin analyzer, which the company claims provides comparable results to blood tests in less than a minute by shining and analyzing light beams on an infant's forehead. Launched overseas in May, the product was cleared in Canada on June 29 ("The Gray Sheet" July 13, In Brief)