Indica Labs, a leading provider of digital pathology solutions, has announced that it has 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 utilised 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 and has transformed the way pathologists and researchers analyse, manage, and utilise digital pathology images according to the company. To address the complex needs of modern pathology laboratories, Indica Labs created HALO AP and HALO AP Dx with 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.

“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.”