NEW YORK – Digital pathology firm Paige announced on Wednesday that it has received CE-IVD marking and UK regulatory approval for its Paige Breast Lymph Node artificial intelligence software.
Along with CE-IVD marking, the software received a UK Conformity Assessed, or UKCA mark. The UK plans to recognize CE-IVD marking until July 2023, by which time, medical device and diagnostic developers will require the UKCA mark for the product to be marketed in the UK.
The Paige Breast Lymph Node tool is intended to help pathologists decide if breast cancer has metastasized to a patient's lymph nodes, the company said in a statement. With the regulatory approvals, laboratories and hospitals in the European Economic Area, Switzerland, and the UK can use the product for clinical diagnosis, it added.
The software has more than 98 percent slide level sensitivity and is available as part of the Paige Breast Suite. It uses the same underlying AI technology as the firm's Paige Prostate device — which received de novo marketing clearance from the US Food and Drug Administration in September — and can be used in any setting that is on the Paige Platform, the company said.
"Through Paige Breast Lymph Node, pathologists can more efficiently identify tumor metastases of any size, including small micrometastases," Juan Retamero, medical director of digital pathology transformation at Paige, said in a statement.
Paige Breast Lymph Node is available for research use only in the US.