The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Indica Labs for the Halo AP Dx digital pathology platform to be used in conjunction with Hamamatsu's NanoZoomer S360MD slide scanner system, according to Hamamatsu Photonics.
Halo AP Dx is indicated for primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue scanned by Hamamatsu's NanoZoomer S360MD. The clearance builds on builds Indica's prior CE-IVDR certification for Halo AP, according to Indica.
Halo AP and Hamamatsu NanoZoomer slide scanners are already in use together for research purposes in the U.S., and in Europe and the U.K. for clinical applications. In the U.S., Indica Labs will continue to offer Halo AP for research use only applications, but will now offer Halo AP Dx for primary diagnosis of surgical pathology slides prepared from FFPE tissue.
