Digital Pathology—Transforming Pathology in Clinical SettingsFDA clearance for the HER2 image analysis application provides clinical customers with access to powerful quantitative image analysis algorithms for breast cancer pathology, while allowing them to benefit from the most advanced digital pathology system available today. Aperio's FDA-cleared digital pathology immunohistochemistry (IHC) image analysis application sets a new stage for the clinical market. It provides HER2 image analysis through its patented ScanScope® slide scanning system and is intended to be used as an aid to pathologists in detecting and quantifying HER2 protein expression from digital slide images created by Aperio’s 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 analyzing digital slides, and the specific image analysis application that performs the automated scoring of IHC HER2 breast cancer digital slides. With an established infrastructure for complying with the FDA’s Quality System Regulation (QSR), Aperio stands poised to extend the clinical utility of digital pathology even further.
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