Paige has received CE-IVD and UKCA marks for a new AI medical device software intended to help pathologists determine if breast cancer has spread to lymph nodes.
With the CE-IVD and UKCA designations, laboratories and hospitals in the European Economic Area, Switzerland and the UK can now use the Paige Breast Lymph Node 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, MD, medical director of 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 was a Gold winner in last year's Medical Device Excellence Awards. The company has developed AI-based tissue diagnostics to help pathologists detect cancers and assess them more quickly and accurately, using a platform trained to recognize tumor features that human eyes may not see.
More recently Paige, Oxford University, and National Health Service (NHS) regional partners in the United Kingdom won the Phase 4 Artificial Intelligence in Health and Care award from the NHS Accelerated Access Collaborative to study Paige Prostate prospectively in a real-world cancer laboratory setting.
Under the award, leaders in uropathology at Oxford University Hospitals, Coventry and Warwickshire University Hospitals Trust, and North Bristol Trust, will develop system adoption guidelines for the Paige Prostate system. These adoption guidelines will enable further roll-out of AI technologies and advanced algorithms across the NHS to aid in the diagnosis of complex diseases.