SpectRx/Healthdyne expect 1997 510(k) submission for non-invasive infant jaundice test -- SpectRx IPO.
This article was originally published in The Gray Sheet
Executive Summary
SPECTRX 510(K) FOR NON-INVASIVE INFANT JAUNDICE TEST will be submitted to FDA this year by partner Healthdyne Technologies, SpectRx says in a June 11 preliminary prospectus for an initial public offering. A prototype version of the test, which is intended to provide bilirubin measurements at the point of care through the use of reflection spectroscopy, currently is being evaluated in pilot trials at three centers.