The HALO AP Dx, an advanced enterprise digital pathology platform, has received FDA clearance for primary diagnosis.
This 510(k) clearance authorizes HALO AP Dx for use with the Hamamatsu NanoZoomer® S360MD Slide scanner for in-vitro diagnostic applications, paving the way for future compatibility with other FDA-approved slide scanners.
It has significantly improved how pathologists and researchers handle digital pathology images worldwide.
It can Developed to address the sophisticated requirements of contemporary pathology laboratories, HALO AP® and HALO AP Dx incorporate a comprehensive range of diagnostic tools and features for precise and efficient image analysis, management, and collaboration.
HALO AP Dx also supports remote work and consultations, addressing the increasing number of cases and the ongoing pathologist shortage. With slides accessible for review immediately after scanning, pathology labs can maintain continuous service and facilitate global collaboration without the need for physical slide shipment.
The 510(k) clearance for HALO AP Dx enables US pathologists to provide timely and accurate diagnoses, accelerating treatment plan development and ensuring quicker patient treatment.
HALO AP Dx is a comprehensive platform for pathology, offering a centralized solution for primary diagnosis, collaboration, tumor boards, and second opinions.
Its powerful integration engine consolidates various functionalities, providing a robust software and hardware diagnostic workspace and a collaborative hub that encourages innovation, adaptability, and future AI readiness.
The importance of FDA clearance for HALO AP Dx, highlighting the commitment to improving patient care by providing an optimal environment for pathology practice and supporting both current and emerging technologies.
Users can customize the platform to fit their needs and seamlessly integrate it into existing laboratory workflows, creating a bespoke digital pathology environment suitable for various pathologic specialties, including those with unique technical requirements.
Source: https://indicalab.com/news/indica-labs-receives-first-fda-clearance-for-halo-ap-dx-digital-pathology-platform/
