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Ventana receives FDA 510(K) clearance for Ki-67 image analysis app

Ventana Medical Systems, a member of the Roche Group, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VENTANA Companion Algorithm Ki-67 (30-9) image analysis application used with the VENTANA iScan Coreo Au scanner running VIRTUOSO software.

Ventana claims that it is the only company that offers an FDA cleared Ki-67 image analysis algorithm for determining Ki-67 expression levels in breast cancer patients.

The 510(k) clearance covers all components of the VENTANA workflow solution used together including the company’s BenchMark slide stainer, Ki-67 (30-9) clone, detection systems, slide scanner and image management software.

Using Ki-67 (30-9) application, pathologists would achieve objective and consistent Ki-67 interpretation provide quantitative results for images with hundreds or thousands of cells.

Ventana Digital Pathology and Workflow vice president Steve Burnell said this most recent addition to the company’s digital pathology portfolio demonstrates its continued commitment to customers by providing them with the most advanced clinical pathology workflow solutions.

FDA clearance has been given to Ventana’s digital read application that allows the pathologist to interpret Ki-67 (30-9) stained slides as images on a computer monitor with the VENTANA iScan Coreo Au scanner and Virtuoso software.