FDA Grants Bilirubin Analyzer Expanded Claims

A noninvasive device that predicts the level of bilirubin in infants has been granted extended claims by the U.S. Food and Drug Administration (FDA). The device may now be used to monitor infant jaundice during and after treatment, in addition to its use as a point-of-care screening tool.

Called BiliChek, the device predicts the level of bilirubin by analyzing light reflected from the baby's forehead, providing readings in less than a minute and eliminating the need to draw blood from an infant's heel and wait for laboratory results. Clinical studies indicate that the BiliChek provides results regardless of the infant's weight, gestational age, or gender. Individual disposable calibration tips are used with the BiliChek to perform automatic calibration prior to each measurement and provide a clean contact point for each infant tested. BiliChek was developed and is manufactured by SpectRx (Norcross, GA, USA).

"The additional claims substantially open the available market for the BiliChek and provide further validation of our biophotonic technology and, importantly, reduce the need for many painful heel stick blood tests, making the first few days of life a little easier for new babies and their parents,” said Mark A. Samuels, chairman and CEO of SpectRx.


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