Paige Lymph Node is an artificial intelligence-based in vitro diagnostic medical device software, designed to identify breast cancer metastases in lymph node tissue
FDA grants Breakthrough Device Designation to Paige Lymph Node. (Credit: Paige AI, Inc.)
Paige has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for Paige Lymph Node application for cancer detection in breast lymph nodes.
Paige Lymph Node is an artificial intelligence (AI)-based in vitro diagnostic medical device software, designed to identify breast cancer metastases in lymph node tissue.
It is said to be the first of its kind AI application to get the FDA’s Breakthrough Device Designation.
The application is derived from a deep learning model that has been trained with more than 32,000 digitised haematoxylin and eosin (H&E) lymph node slides.
Paige CEO Andy Moye said: “We are thrilled with the decision from the FDA to recognise the importance of AI in managing metastatic disease in breast cancer patients.
“The Paige Lymph Node algorithm saves pathologists time and provides critical information for pathologists to support their diagnosis amidst unprecedented demands and resource constraints.”
According to Paige, the sensitivity of the Paige Lymph Node in breast cancer metastases identification is near perfect.
The medical device software will indicate each area of concern for additional evaluation by the pathologist if the lymph node tissue is suspected of cancer. This will make the process of diagnosis and assessment simpler and more effective, Paige added.
Paige founder and chief medical officer David Klimstra said: “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.
“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.”
Previously, Paige received the breakthrough designation for Paige Prostate Detect, an AI application intended to help identify malignant prostate tissue.
The FDA has also authorised Paige FullFocus, a whole-slide image viewer, for use in primary diagnosis.
The company provides clinical AI applications and end-to-end digital pathology solutions to help with the diagnosis of cancer.