May 8, 2024—Indica Labs received FDA 510(k) clearance for its Halo AP Dx digital pathology platform for use in primary diagnosis. The clearance allows the platform to be used with the Hamamatsu NanoZoomer S360MD Slide scanner for in vitro diagnostic use.
“Our team is thrilled to achieve this FDA clearance for Halo AP Dx,” Steven Hashagen, founder and CEO of Indica Labs, said in a press release. “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 Dx can be deployed in a cloud-based or on-premises environment and enables remote work and remote consultations.