Indica Labs Achieves FDA Clearance for HALO AP Dx Platform

Indica Labs, a leader in digital pathology solutions, has announced FDA clearance for its HALO AP Dx platform for primary diagnosis in the United States. The clearance, under the 510(k) protocol, enables the platform's use with the Hamamatsu NanoZoomer® S360MD Slide scanner for in-vitro diagnostic applications, with potential future expansions to other FDA-cleared slide scanners.

HALO AP Dx is designed to enhance efficiency and accuracy in image evaluation and management within pathology labs, supporting both cloud-based and on-premises data storage. This adaptability allows for integration into various lab workflows and facilitates remote diagnostic processes and consultations, crucial during increasing pathologist shortages and heavy caseloads.

Steven Hashagen, CEO of Indica Labs, emphasized the platform's role in advancing patient care through timely and precise diagnostics, which are expected to expedite treatment plans. The platform's flexibility, interoperability, and readiness for future AI integration position it as a comprehensive solution for pathology practices seeking robust diagnostic and collaborative capabilities.