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SpectRx

This article was originally published in The Gray Sheet

Executive Summary

Receives marketing clearance in Canada for the BiliCheck non-invasive bilirubin analyzer, which is designed to replace heel stick blood tests for infant jaundice. The device, which began international sales in May, shines, collects and analyzes light from the infant's forehead to test for jaundice regardless of the infant's skin color, gestational age or post-natal age, the company says. SpectRx expects to file a 510(k) for the product this summer
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