Indica Labs, and Hamamatsu Photonics K.K., have announced that the US 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 the primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue scanned by the NanoZoomer® S360MD Slide scanner. This 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 expressed, "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® is a case-centric digital pathology platform deployed worldwide, transforming the way pathologists and researchers analyze, manage, and utilize digital pathology images. It offers a comprehensive suite of tools and features for efficient and accurate image evaluation, management, and collaboration. HALO AP® and Hamamatsu NanoZoomer Slide scanners are already in use together at various 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 the primary diagnosis of surgical pathology slides prepared from FFPE tissue.

The NanoZoomer® S360MD Slide scanner system is a meticulously crafted digital pathology solution that displays images and provides image management tools. It aids qualified pathologists in the review and interpretation of digital images of surgical pathology slides prepared from FFPE tissue.

Fumio Iwase, Executive Officer, Division Director, Systems Division at Hamamatsu Photonics K.K. commented, "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."

"This regulatory achievement represents a significant stride forward, underscoring our joint commitment to providing cutting-edge solutions that elevate standards in the digital pathology field and empower professionals in their diagnostic endeavors," added Iwase.