FDA EUA

By Jonah Comstock April 13, 2017
Nanobiosym, the Cambridge, Massachusetts-based digital health company whose Gene-RADAR scanner won the Nokia Sensing X Prize a few years ago, has been granted Emergency Use Authorization (EUA) from the FDA for its Zika Virus Test.  EUA is a special clearance pathway the FDA uses for devices that address an immediate public health crisis like Zika. Devices authorized under EUA aren’t cleared or...