HALO AP Dx is an FDA-cleared case-centric pathology platform that enables primary diagnosis, remote working, and other routine workflows in anatomic pathology. The browser-based interface makes it easy to consult with other pathologists, manage clinical trials, run tumor boards, and more. For more information, visit HALO AP Dx’s product page.
Regulatory Compliance
HALO AP Dx (K232833) is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomer® S360MD Slide scanner in the US. In addition, HALO AP Dx provides built-in compliance and certifications with FDA 21 CFR Part 11, ISO 13485:2016, and HIPAA.