Indica Labs receives first FDA clearance for HALO AP Dx digital pathology platform

May 9, 2024
HALO AP Dx is FDA-cleared for primary diagnostic use with the Hamamatsu NanoZoomer S360MD Slide scanner in the US.

Indica Labs announced that it received FDA clearance for HALO AP Dx, an enterprise digital pathology platform, for primary diagnosis.

This 510(k) clearance allows HALO AP Dx to be utilized in conjunction with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic use and sets the stage for use with additional FDA-cleared slide scanners in the future. 

HALO AP is an enterprise digital pathology platform that is deployed worldwide. In the US, Indica Labs will continue to offer HALO AP for RUO applications and will now offer HALO AP Dx for primary diagnosis. 

HALO AP Dx users can adapt the platform to meet their needs and incorporate it into their existing laboratory workflows by creating a custom-built environment for digital pathology and for a variety of pathologic specialties, even those with unique technical requirements. HALO AP Dx can be deployed in either a cloud-based or on-premises environment, granting users freedom of choice as to how their data is stored. 

HALO AP Dx enables both remote work and remote consultations.

To learn more about HALO AP Dx and to see a live demo, register for Indica Labs’ upcoming webinar. “Introducing HALO AP Dx: An Enterprise Pathology Platform for Primary Diagnosis” will take place on Thursday, June 13 at 11AM EDT.  

Indica Labs release