In a significant advancement for cancer detection technology, Paige’s Lymph Node application has been granted the Breakthrough Device Designation by the US Food and Drug Administration (FDA). This artificial intelligence (AI)–powered in vitro diagnostic medical device software is specifically designed to detect breast cancer metastases in lymph node tissues.
First of Its kind
The Paige Lymph Node stands out as the inaugural AI application to receive the FDA’s Breakthrough Device Designation. This distinction underscores the potential and importance of AI in revolutionizing medical diagnostics.
Deep learning at its’ core
The technology behind Paige Lymph Node is rooted in a deep learning model. This model has been meticulously trained using over 32,000 digitized haematoxylin and eosin (H&E) lymph node slides, ensuring a robust and comprehensive foundation for its diagnostic capabilities.
A word from Paige’s leadership
Paige’s CEO, Andy Moye, expressed his enthusiasm regarding the FDA’s decision, emphasizing the pivotal role of AI in managing metastatic breast cancer. He stated, “The Paige Lymph Node algorithm saves pathologists time and provides critical information for pathologists to support their diagnosis amidst unprecedented demands and resource constraints.”
Near-perfect sensitivity
One of the standout features of the Paige Lymph Node is its remarkable sensitivity in identifying breast cancer metastases. According to Paige, the device’s accuracy is near flawless. When the software detects potential cancer in the lymph node tissue, it highlights the areas of concern. This feature aids pathologists by streamlining the diagnostic process, making it both simpler and more effective.
Expert insights
David Klimstra, Paige’s founder and chief medical officer, shed light on the importance of this technology. He emphasized the critical role of pathologic assessments of lymph nodes in predicting outcomes and determining treatment for breast cancer patients. Klimstra noted, “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.”
Previous recognitions
This isn’t Paige’s first foray into groundbreaking AI applications. The company had previously been recognized with the breakthrough designation for Paige Prostate Detect, another AI tool designed to pinpoint malignant prostate tissue. Additionally, the FDA has authorized Paige FullFocus, a comprehensive whole-slide image viewer, for primary diagnosis purposes.
About Paige
Paige is at the forefront of integrating AI into clinical applications, with a primary focus on cancer diagnosis. The company offers a suite of end-to-end digital pathology solutions, aiming to enhance the accuracy and efficiency of cancer detection and treatment.
The FDA’s Breakthrough Device Designation for Paige’s Lymph Node application marks a significant milestone in the integration of AI into medical diagnostics. As technology continues to evolve and intertwine with healthcare, tools like Paige Lymph Node pave the way for more accurate, efficient, and timely cancer diagnoses, ultimately leading to better patient outcomes.
