U.S. FDA Grants Paige Breakthrough Device Designation for Cancer Detection in Breast Lymph Nodes

Paige Lymph Node is recognized by the FDA as a breakthrough device to assist pathologists in the detection of breast cancer metastases in lymph node tissue

Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications that assist in diagnosing cancer, announced today that the U.S Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Paige Lymph Node1, an AI application used to detect breast cancer metastases in lymph node tissue. Paige Lymph Node is the first AI application of its kind to receive Breakthrough Device Designation from the FDA.

The FDA’s Breakthrough Device Designation is granted for technologies that have the potential to provide for more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. For these technologies, timely availability is in the best interest of patients because no approved alternative exists or because the technology offers significant advantages over existing approved alternatives4.

“Pathologic assessment of lymph nodes in breast cancer patients is critically important for prediction of outcome and treatment, yet the process is time-consuming and error prone,” said David S. Klimstra, M.D., Founder and Chief Medical Officer at Paige. “Paige Lymph Node uses the power of AI to help the pathologist identify even small lymph node metastases rapidly and accurately, ensuring that breast cancer patients receive the optimal management of their disease.”

Paige Lymph Node is an in vitro diagnostic medical device software, derived from a deep learning model that has been trained with over 32,000 digitized hematoxylin & eosin (H&E) lymph node slides. Paige Lymph Node detects the presence of breast cancer metastases with near-perfect sensitivity3. If the lymph node tissue is suspicious for cancer, Paige Lymph Node will highlight each area of concern for further review by the pathologist, making it easier and more efficient for them to assess and reach a diagnosis.

“We are thrilled with the decision from the FDA to recognize the importance of AI in managing metastatic disease in breast cancer patients,” said Andy Moye, PhD, CEO of Paige. “The Paige Lymph Node algorithm saves pathologists time and provides critical information for pathologists to support their diagnosis amidst unprecedented demands and resource constraints.”

Paige previously achieved breakthrough designation for Paige Prostate Detect2, an AI application designed to assist in the identification of cancerous prostate tissue, before earning the distinction of becoming the first and only FDA-authorized digital pathology application to date. Paige FullFocus®2, a whole-slide image viewer, has also been approved by the FDA for use in primary diagnosis.


  1. In the United States, Paige Lymph Node is for research use only and should not be used in diagnostic procedures.
  2. In the United States, Paige Prostate Detect (DEN200080) approved for clinical use with Philips Ultrafast Scanner.
  3. Based on an investigational clinical study conducted by Paige involving 3 pathologists and data from 148 patients.
  4. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program

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