NEW YORK– 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.
