Aperio Technologies has received clearance from the US Food and Drug Administration (FDA) to market the HER2 image analysis application available through its patented ScanScope slide scanning system. The FDA-cleared immunohistochemistry (IHC) image analysis application is intended for use as an aid in detecting and quantifying HER2 protein expression from digital slide images created by AperioÆs slide scanning systems.
Aperio’s FDA clearance encompasses the company’s complete digital pathology system, including ScanScope scanners for creating digital slide images from microscope slides, the Spectrum digital pathology information management system for managing, viewing and analysing digital slides, and the specific image analysis application that performs the automated scoring of IHC HER2 breast cancer digital slides.
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