FDA clearance arms pathologists with digital technology to help assess treatment options for breast cancer patients
PITTSBURGH -- April 14, 2014 -- GE Healthcare and UPMC today announced that the Omnyx™ Manual Read of the Digital HER2 Application has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance will allow the OmnyxTM system to be marketed in the U.S. for this intended use. Omnyx, LLC is a joint venture of UPMC and GE Healthcare.