Very nice read by Dr. Holger Lange of Flagship Biosciences in this month's ASCP LabMedicine (subscription required) on regulatory issues in digital pathology.  Holger provides a clear overview of the issues pertinent...

The following post was submitted by Dr. Holger Lange, CTO of Flagship Biosciences, who is working with a number of pharmaceutical partners on regulatory companion diagnostics development. Digital Pathology is a new technology, a new industry,...

In this series of posts on Laboratory Developed Tests (LDTs), I discuss the history of the regulation of LDTs and impending changes (posts #1 and #2).  I also discuss possible criteria that pathologists, treating physicians, and...

By guest author Amanda Lowe of Digital Pathology Consultants, LLC The FDA Hematology and Pathology devices advisory panel, who discussed whole slide imaging (WSI) and its use for primary diagnosis in surgical pathology last week, will use...

By guest author Amanda Lowe of Digital Pathology Consultants, LLC The FDA Hematology and Pathology devices advisory panel meeting, open to the public and being held in Gaithersburg, Maryland, began this morning to discuss Whole Slide Imaging...