NEW YORK (GenomeWeb) – Clearbridge BioMedics said today that it has registered its target cell enrichment device, the ClearCell FX1 system, as a Class I medical device with the US Food and Drug Administration.

ClearCell is a label-free, microfluidics-based liquid biopsy device that allows for the enrichment of target cells from blood. The system had previously been CE-marked for in vitro diagnostic use in Europe, and was available in China as a China FDA-approved device. It was commercially launched in 2015.

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