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...

Newly released artificial intelligence (AI)-driven TissueMark software[1] empowers research labs to enhance quality and reliability, and reduce costs AMSTERDAM and VANCOUVER, British Columbia, March 15, 2018 -- Royal Philips (NYSE: PHG,...

By Christopher Ivicevich, Director of Regulatory Affairs & Quality Compliance, OptraSCAN With the recent shift in the industry as the result of this decision, a common question is “What lies in store for digital pathology system...