BRIDGEWATER, N.J., May 22, 2024 /PRNewswire/ — 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.

Steven Hashagen, founder and CEO of Indica Labs said, “This FDA clearance for primary diagnosis of surgical pathology slides prepared from FFPE tissue is a significant milestone for HALO AP Dx that builds upon our prior CE-IVDR certification for HALO AP®. We’re proud that our collaboration with Hamamatsu allowed us to leverage images from their NanoZoomer Slide scanner and led directly to this landmark achievement that will provide value to patients and healthcare providers alike.”