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FDA approval
Paige receives breakthrough device designation from FDA
AI Drug Discovery
Oct 26, 2023
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AI Drug Discovery

AI Drug Discovery

Oct 26, 2023

Paige receives breakthrough device designation from FDA

FDA approval

  • New York-based AI biotechnology company Paige has received breakthrough device designation from the FDA for its breast cancer detection tool Paige Lymph Node.

  • Paige Lymph Node is an in-vitro diagnostic medical device software based on a deep learning model trained using over 32,000 digitized hematoxylin and eosin lymph node slides. It is capable of detecting breast cancer metastases in lymph node tissue including the detection of suspicious areas of potential breast cancer metastasis, identification of breast cancer micro-metastases and isolated tumor cells in lymph node tissue, and enhanced diagnostic accuracy and confidence.

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