The FDA last week said it approved a 1st-of-its-kind device designed to treat patients with dialysis-related buildup of amyloid protein in the body made by Japan’s Kaneka (TYO:4118).
The safety watchdog said it granted a humanitarian device exemption for Kaneka’s Lixelle Beta 2-microglobulin apheresis column, a designation given to devices meant to diagnose or treat rare diseases affecting less than 4,000 people annually.
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