GE Healthcare's Omnyx integrated digital pathology (IDP) product with the new VL120 high-volume scanner has received a CE Mark for primary diagnosis in Europe under the EU's in vitro devices directive, the company said.
The approval represents an upgrade from last year's CE clearance, when Omnyx IDP was approved for use with the Omnyx VL4 slide scanner for lower-volume uses, the company said. That product has been placed in Switzerland, Spain, and the U.K.
The higher volume scanner offers histopathologists greater speed and efficiency for scanning slides, creating case files, and managing their workflow, GE said. Omnyx IDP was developed by a joint venture of GE Healthcare and the University of Pittsburgh Medical Center in Pennsylvania, GE added.
Until now there has been a dearth of investment in technology for pathologists, who often have to travel to remote laboratories or wait to receive slides, creating delays in diagnosis and a risk of damage or loss, GE said.
