There are two whole-slide scanning systems on the market with FDA clearance for clinical applications, but they are for FFPE slides only, which means they cannot be used for frozen sections or fine needle aspirations. All other scanning systems are meant to be used for research, education, or archival purposes only. However, due to the COVID-19 pandemic, the FDA has issued a policy to allow the use of digital pathology devices when they are intended for use in remote reviewing and reporting of digital pathology slides.
Read the FDA’s emergency use authorization.
Learn more about digital pathology.