NEW YORK – Indica Labs announced Wednesday that its Halo AP Dx digital pathology platform has received 510(k) clearance from the US Food and Drug Administration.
Under the clearance, the Halo platform can be used with the Hamamatsu NanoZoomer S360MD Slide scanner for in vitro diagnostic use. Indica Labs said in a statement that it will continue to offer its Halo AP platform for research-use-only applications and its Halo AP Dx platform for primary diagnosis in the US. Both platforms offer a suite of diagnostic tools and features for image evaluation, management, and collaboration, the company said.
Users of the Halo AP Dx platform can incorporate it into their existing laboratory workflows and create a custom-built environment for digital pathology and for a variety of pathologic specialties, the Albuquerque, New Mexico-based firm added. It can also be deployed in both cloud-based and on-premises environments and enables both remote work and remote consultations.
"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," Indica Founder and CEO Steven Hashagen said in a statement.
Halo AP has CE-IVDR marking for diagnostic use in Europe, the UK, and Switzerland, the company noted.