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.
HALO AP is a case-centric digital pathology platform that is deployed worldwide. 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 a digital pathology scanner 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.
HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP provides built-in compliance and certifications with FDA 21 CFR Part 11, HIPAA, and GDPR.
