FDA expands use for SpectRx' noninvasive Bilichek:
This article was originally published in Clinica
SpectRx has received US FDA 510(k) marketing clearance to expand the use of its BiliChek noninvasive test for infant jaundice. The BiliChek device, which assesses bilirubin levels in the skin, can now be used to monitor jaundice during and after treatment for the condition, in addition to its use as a point-of-care screening tool. "The additional claims substantially open the available market for the BiliChek," says Mark Samuels, SpectRx' chairman and CEO. The test is sold in the US by Respironics. More than two million babies are affected by infant jaundice every year in the US.