Indica Labs has announced that it 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, created by Indica Labs 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 research-use-only 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.”
Owing to the company’s commitment to open pathology, the platform is highly interoperable. HALO AP Dx users can adapt the platform to meet their needs and incorporate it into their existing laboratory workflows with ease, creating a custom-built environment for digital pathology and for a variety of pathologic specialties, even those with unique technical requirements. HALO AP Dx is flexible and can be deployed in either a cloud-based or on-premises environment, granting users freedom of choice as to how their data is stored.
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.”