This significant 510(k) clearance permits the use of HALO AP Dx in conjunction with the Hamamatsu NanoZoomerS360MD Slide scanner for in-vitro diagnostic use and paves the way for its future compatibility with additional FDA-cleared slide scanners.
HALO AP is a globally deployed enterprise digital pathology platform that Indica Labs says has revolutionized the analysis, management, and utilization of digital pathology images for pathologists and researchers.
To meet the intricate demands of contemporary pathology laboratories, the company developed HALO AP and HALO AP Dx, which offer a comprehensive suite of diagnostic tools and features designed for efficient and precise image evaluation, management, and collaboration. In the US, Indica Labs will continue to offer HALO AP for research use only (RUO) applications, while HALO AP Dx will be available 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.”
Pathology across specialties including unique requirements
Due to the company’s commitment to open pathology, it says the HALO AP Dx platform is highly interoperable, allowing users to adapt it to their needs and seamlessly integrate it into existing laboratory workflows. This flexibility enables the creation of a custom-built environment for digital pathology across various pathologic specialties, including those with unique technical requirements.
Additionally, the platform can be deployed in either a cloud-based or on-premises environment, providing users with options for data storage.
Beyond streamlining the diagnostic process, the platform supports remote work and consultations, critical features amid a growing pathologist shortage. With slides accessible for review from any location as soon as they are scanned, pathology labs can maintain uninterrupted services and facilitate round-the-clock, global collaboration without the need to physically ship slides.
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.”
Indica Labs, says this is a complete platform for pathology, offering a centralized solution for primary diagnosis, collaboration, tumor boards, and second opinions. Its powerful integration engine unifies diverse software and hardware functionalities, providing pathology practices with not only a robust diagnostic workspace but also a collaborative hub that promotes innovation, adaptability, and readiness for future AI advancements. Leading hospitals, CROs, clinical laboratories, and government and academic organizations rely on HALO AP to deliver the power and usability required for modern pathology practices.
