Indica Labs and Hamamatsu Photonics K.K announced that the U.S. Food and Drug Administration (FDA) has issued a 510(k) clearance to Indica Labs for HALO AP Dx, an enterprise digital pathology platform. HALO AP Dx is indicated for primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue scanned by the NanoZoomer S360MD Slide scanner. This 510(k) clearance from the FDA expands on an established partnership between Indica Labs and Hamamatsu Photonics K.K. HALO AP is a case-centric digital pathology platform that is deployed worldwide and has transformed the way pathologists and researchers analyze, manage, and utilize digital pathology images through its comprehensive suite of tools and features for efficient and accurate image evaluation, management, and collaboration.

HALO AP® and Hamamatsu NanoZoomer Slide scanners are already in use together at a variety of institutions and centers in the US for research purposes, and in the EU and the UK for clinical applications. In the US, Indica Labs will continue to offer HALO AP® for Research Use Only applications, and will now also offer HALO AP Dx for primary diagnosis of surgical pathology slides prepared from FFPE tissue. The NanoZoomer S360MD Slide scanner system is an expertly crafted digital pathology solution that displays images and provides image management tools and aids qualified pathologists in the review and interpretation of digital images of surgical pathology slides prepared from FFPE tissue.