Paige Prostate was granted de novo marketing authorization from the FDA to aid in the primary diagnosis of prostate cancer. NEW YORK--(BUSINESS WIRE)--Paige, the global leader in AI-based diagnostic software in pathology, today announced...

An event for the modern diagnostic lab. Join Proscia, pathology leaders, and healthcare innovators for a can’t-miss event for diagnostic laboratories: Future Ready Pathology. June 15, 2021  |  11AM - 12:15PM ET As pathology labs...

Health and Human Services (HHS) is seeking public comments on making permanent regulatory flexibilities provided during the COVID–19 public health emergency by exempting certain medical devices from premarket notification requirements;...

The FDA has issued guidance aimed at expanding the use of remote digital pathology devices during the COVID-19 pandemic. In response to the FDA’s guidance, Proscia announced today that we are now offering our Concentriq Dx digital...

Leica Biosystems, the global leader in pathology workflow solutions, announced it has received notification from the U.S. Food & Drug Administration (FDA) that its Aperio ImageScope DX Viewer with images acquired on the Aperio AT2 DX...

Congratulations to Paige.AI for obtaining Breakthrough Device designation. My recollection from a final guidance issued by the FDA late last year and taken from their own news release: "The [Breakthrough Device] program was established by the...