Digital pathology solutions provider Indica Labs has received the US Food and Drug Administration (FDA) 510(k) clearance for HALO AP Dx, an enterprise digital pathology platform.
The clearance will allow HALO AP Dx to be used with Hamamatsu Photonics’ NanoZoomer S360MD Slide scanner for in-vitro diagnostic use.
The digital pathology platform is indicated for the primary diagnosis of surgical pathology slides derived from formalin-fixed paraffin embedded (FFPE) tissue, which are scanned using the NanoZoomer S360MD Slide scanner.
The latest development also expands an established partnership between Indica Labs and Hamamatsu Photonics.
Indica Labs founder and CEO Steven Hashagen 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.”
HALO AP Dx, based on the HALO AP platform, provides a range of tools and features for precise and efficient analysis, management, and collaboration with digital pathology images.
Its integration with Hamamatsu NanoZoomer Slide scanners is already established in various institutions and centres across the US for research work and for clinical purposes in the European Union and the UK.
In the US, Indica Labs will continue offering HALO AP for Research Use Only, while also introducing HALO AP Dx for the primary diagnosis of surgical pathology slides derived from FFPE tissue.
The NanoZoomer S360MD Slide scanner system showcases images and offers image management tools. It also assists qualified pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from FFPE tissue.
Hamamatsu Photonics executive officer Fumio Iwase said: “We believe that comprehensive tools are key to the advancement of digital pathology.
“The 510(k) clearance of the Indica Labs HALO AP Dx for review of images acquired with the previously 510(k)-cleared NanoZoomer S360MD Slide scanner system is a testament to the unwavering quality and confidence that both partners consistently deliver to our valued customers.”
