FDA Clears Indica Labs’ HALO AP Dx Digital Pathology Platform

Indica Labs has received 510(k) clearance from the FDA for its HALO AP Dx digital pathology platform for primary diagnosis. This clearance allows HALO AP Dx to be utilized with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic use. This also helps promote additional FDA-cleared slide scanners in the future.
 
“Our team is thrilled to achieve this FDA clearance for HALO AP Dx,” said Steven Hashagen, founder and CEO of Indica Labs. “Indica Labs is dedicated to improving patient care by providing an ideal environment for the practice of pathology that supports both current and future technologies, ensuring pathologists have the best tools available at their fingertips and are prepared for whatever the future of digital pathology holds.”
 
HALO AP is an enterprise digital pathology platform that has been deployed worldwide and has transformed the way pathologists and researchers analyze, manage, and utilize digital pathology images. 
 
HALO AP and HALO AP Dx include a comprehensive suite of diagnostic tools and features for efficient and accurate image evaluation, management, and collaboration. 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 is a complete platform for pathology and a centralized solution for primary diagnosis, collaboration, tumor boards, and second opinions. Its powerful integration engine brings together diverse software and hardware functionalities.
 
The HALO AP Dx platform is interoperable and adaptable to be incorporated into existing laboratory workflows. Users can create a custom-built environment for digital pathology and for a variety of pathologic specialties. HALO AP Dx can be deployed in either cloud-based or on-premises environments.
 
Hashagen added, “This 510(k) clearance for HALO AP Dx enables pathologists in the US to deliver timely and accurate diagnoses, expediting the development of treatment plans and ultimately resulting in patients being treated sooner, which enhances patient care. We’ve already witnessed these improvements to patient care in the UK, where the platform is CE-IVDR marked for in-vitro diagnostic use, and we look forward to similar outcomes here in the US.”
 
HALO AP Dx also enables both remote work and remote consultations. Slides can be reviewed from any location the moment they are scanned, allowing pathology labs to run uninterrupted pathology services with round-the-clock, global collaboration without having to ship slides.