Paige Earns CE-IVD and UKCA Marks for Clinical AI Application to Detect Breast Cancer Metastases in Lymph Nodes
Paige , a global leader in clinical AI applications in pathology, today announced it received CE-IVD and UKCA marks for Paige Breast Lymph Node. The newly launched AI medical device software helps pathologists detect if breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review. With the CE-IVD and UKCA designations, laboratories and hospitals in the European Economic Area, Switzerland and the UK can now use the product in the course of clinical diagnosis.*
“Paige’s aim is to provide pathologists with innovative, care enhancing technology so they can provide the best possible insights to patients. Through Paige Breast Lymph Node, pathologists can more efficiently identify tumor metastases of any size, including small micrometastases,” said Juan Retamero, M.D., Medical Director, Digital Pathology Transformation at Paige. “The CE-IVD and UKCA marks for Paige Breast Lymph Node are a vital step towards increasing the adoption of our new tool in European hospitals and laboratories.”
Paige Breast Lymph Node uses the same underlying AI technology as Paige Prostate and can be deployed in any laboratory or hospital setting that is on the Paige Platform.
*Paige Breast Lymph Node is available for “Research Use Only ” in the United States, not for use in diagnostic procedures.
Paige was founded in 2017 by Thomas Fuchs, Dr.Sc., David Klimstra, M.D., and colleagues from Memorial Sloan Kettering Cancer Center (MSK). The company builds computational pathology products designed so patients and their care teams can make effective, more informed treatment decisions. With this new class of AI-based technologies positioned to drive the future of diagnostics, Paige created a platform to deliver this novel technology to pathologists to transform their workflow and increase diagnostic confidence and productivity. Paige’s products deliver insights to pathologists and oncologists so they can arrive efficiently at more precise diagnoses for patients. Paige is the first company to receive FDA approval for an AI-based digital pathology product.
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