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ER image-analysis algorithm, 2/14

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February 2014—Ventana Medical Systems received 510(k) clearance from the FDA for the Companion Algorithm ER (SP1) image-analysis algorithm used with the Ventana iScan Coreo scanner running Virtuoso software.

There are two intended uses obtained with the 510(k) clearance for ER: clinical use of the software algorithm to semi-quantify the ER biomarker and digital read, or clearance, to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope. The pathologist will be able to digitally view a slide on a computer monitor, assign a score, and then sign out the case with a diagnosis or opinion, with or without the assistance of an image-analysis algorithm.

Ventana Medical Systems, 520-877-7288

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