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FDA Grants 510(k) Clearance for Digital HER2 Status Test

doi: 10.1097/01.COT.0000438520.95596.f4

The U.S. Food and Drug Administration has granted 510(k) clearance to Her2/neu IHC Digital Manual Read (Philips), a digital system to assess HER2 status in breast cancer patients to help determine treatment options. The 510(k) allows for the device to be marketed in the U.S., and demonstrates the device is safe and effective.



Her2/neu IHC Digital Manual Read is an automated digital slide creation system. It allows pathologists to use digitally stored Her2/neu IHC images to help them in the detection and semi-quantitative measurement of immunohistochemically (IHC) stained breast cancer tissue on their computer monitor.

The system was previously commercially introduced in Europe and Asia Pacific in 2012.

© 2013 by Lippincott Williams & Wilkins, Inc.
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