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;...

Linköping, Sweden and Shelton, CT – International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Leica Biosystems announce collaboration for an integrated clinical pathology solution. The goal is to address the...

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...

Last week news was released after months of speculation, that the FDA would consider the de novo classification option for digital pathology systems as a pathway for bringing to market a moderate or low risk device which has not yet been...

More positive news coming from Ventana with its CE Mark in the EU for routine pathology, including primary diagnosis.   New CE mark in the European Union extends application to routine pathology including primary diagnosis with human tissue...