U.S. FDA Bestows Paige with Breakthrough Device Designation for Detecting Breast Lymph Node Cancer

Friday, October 27, 2023

Paige, a global leader in the realm of comprehensive digital pathology solutions and clinical AI applications dedicated to enhancing cancer diagnosis, has made a significant announcement. The U.S. Food and Drug Administration (FDA) has bestowed its coveted Breakthrough Device Designation upon Paige Lymph Node1, an AI application tailored for the detection of breast cancer metastases within lymph node tissue. 

The FDA's Breakthrough Device Designation is an exclusive recognition reserved for technologies demonstrating the potential to substantially advance the diagnosis and treatment of life-threatening or debilitating diseases. This recognition is particularly reserved for situations where no approved alternatives are available or where the technology offers notable advantages over existing approved alternatives4.

Paige Lymph Node is an in vitro diagnostic medical device software that has its roots in a deep learning model, meticulously trained on over 32,000 digitized hematoxylin & eosin (H&E) lymph node slides. This state-of-the-art technology boasts an exceptional sensitivity3 in detecting breast cancer metastases. 

Prior to achieving this distinction, Paige had previously secured Breakthrough Device Designation for Paige Prostate Detect2, an AI application designed to aid in the identification of cancerous prostate tissue. This landmark achievement established Paige as the first and only FDA-authorized digital pathology application of its kind to date. Furthermore, Paige FullFocus®2, a whole-slide image viewer, has received FDA approval for its use in primary diagnostic applications.


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