Indica Labs' HALO AP Dx Digital Pathology Platform Cleared by FDA for Use with Hamamatsu NanoZoomer® S360MD Slide Scanner

Friday, May 24, 2024

Indica Labs, a leader in AI-powered digital pathology solutions, and Hamamatsu Photonics K.K., known for their whole slide imaging systems, have announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Indica Labs for HALO AP Dx, an advanced digital pathology platform.

This platform is now approved for the primary diagnosis of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue, using the NanoZoomer® S360MD Slide scanner. This clearance builds on the strong partnership between Indica Labs and Hamamatsu Photonics K.K.

The founder and CEO of Indica Labs, commented, "Securing FDA clearance for the primary diagnosis of FFPE tissue surgical pathology slides is a crucial achievement for HALO AP Dx, following our prior CE-IVDR certification for HALO AP®.

The collaboration with Hamamatsu and the use of images from their NanoZoomer Slide scanner were pivotal in reaching this significant milestone, which will greatly benefit patients and healthcare providers."

HALO AP® is a globally utilized, case-centric digital pathology platform that transforms the analysis, management, and utilization of digital pathology images through a suite of tools designed for efficient and accurate image evaluation, management, and collaboration.

HALO AP® and the Hamamatsu NanoZoomer Slide scanners are already employed together in various research institutions and clinical centers across the US, EU, and UK. In the US, Indica Labs will continue offering HALO AP® for research purposes and now HALO AP Dx for primary diagnosis of FFPE tissue surgical pathology slides.

The NanoZoomer® S360MD Slide scanner system is a high-quality digital pathology solution that aids pathologists in reviewing and interpreting digital images of FFPE tissue surgical pathology slides through advanced image display and management tools.

Executive Officer and Division Director of the Systems Division at Hamamatsu Photonics K.K., stated, "The development of comprehensive tools is vital for the progress of digital pathology. The 510(k) clearance of Indica Labs’ HALO AP Dx, when used with our previously cleared NanoZoomer® S360MD Slide scanner system, reflects our commitment to quality and reliability.

This regulatory milestone underscores our dedication to providing state-of-the-art solutions that enhance digital pathology standards and support diagnostic professionals."

1HALO AP Dx (K232833) is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomer® S360MD Slide scanner in the US. Furthermore, HALO AP Dx complies with FDA 21 CFR Part 11 and HIPAA regulations.

HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. In the US, HALO AP is intended for Research Use Only and is not FDA-cleared for clinical diagnostic use. HALO AP also adheres to FDA 21 CFR Part 11, HIPAA, and GDPR standards.


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