Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform for use with Hamamatsu images acquired with the NanoZoomer® S360MD slide scanner

  • Hamamatsu Corporation

BRIDGEWATER, NJ., May 22, 2024  -- Indica Labs, an industry leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., a pioneer in whole slide imaging systems, announce 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 scanner1. This 510(k) clearance from the FDA expands on an established partnership between Indica Labs and Hamamatsu Photonics K.K.

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