The HALO AP Dx software is designed for review of images acquired with the NanoZoomer S360MD Slide scanner. Credit: Indica Labs.

Indica Labs has received 510(k) clearance from the US Food and Drug Administration (FDA) for its enterprise digital pathology platform, HALO AP Dx.

This approval allows the platform to be used for primary diagnosis of surgical pathology slides, specifically those scanned by the NanoZoomer S360MD Slide scanner from Hamamatsu Photonics.

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Designed for use with formalin-fixed paraffin-embedded (FFPE) tissue, the HALO AP Dx platform is part of a growing partnership between Indica Labs and Hamamatsu Photonics.

The case-centric platform is already deployed globally, allowing pathologists and researchers to analyse, manage, and utilise digital pathology images with its extensive suite of tools.

Institutions across the US have been using HALO AP and Hamamatsu NanoZoomer Slide scanners for research while clinical applications are underway in the EU and the UK.

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.”

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With this FDA clearance, Indica Labs can now offer HALO AP Dx for primary diagnosis in the US, alongside its existing research-only applications.

The NanoZoomer S360MD Slide scanner system is a sophisticated digital pathology solution that assists pathologists in the review and interpretation of digital images of FFPE tissue slides.

HALO AP Dx is compliant with FDA 21 CFR Part 11 and HIPAA regulations, ensuring secure and reliable operation within clinical environments.

Hamamatsu Photonics K.K. Systems Division division director, executive officer Fumio Iwase said: “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.”

The platform also holds CE-IVDR marking for in-vitro diagnostic use in the UK, Europe and Switzerland. For the US market, HALO AP remains a research-only tool, not yet FDA-cleared for clinical diagnostics.

In 2022, Indica Labs obtained a CE-IVD Mark for its screening tool, HALO Prostate AI, designed to enable pathologists to identify and grade prostate cancer in core needle biopsies.