chalk tip #39: Aperio FDA clearances

Hi everyone...  it's been a while since my last chalk tip and I'm getting back into the habit :)

I get asked a lot about Aperio's FDA clearances...  people want to understand exactly which applications are FDA cleared, and all the details.  The detailed information on each filing is posted on our website, including links to the corresponding FDA premarket notification database entries.  There are also links to the press releases announcing each clearance.

Here is a list of our current FDA clearances, linked to the details:

• HER2 Image Analysis - K071128
• Manual Read of HER2 Digital Slides - K071671
• ER/PR Image Analysis - K073677
• IHC PR Breast Tissue Manual Read of Digital Slides - K080254
• HER2 Image Analysis for Breast Tissue – K080564

It is important to note that Aperio products are FDA-cleared for specific clinical applications, and are intended for research use for other applications.