On June 30, PathAI announced that the updated version of its AISight Dx pathology slide image management software, used to assist in the initial diagnosis and full-slide image management and review, has received 510(k) marketing clearance from the U.S. Food and Drug Administration.

The company stated that the approval includes a Pre-determined Change Control Plan (PCCP), enabling it to update the software to integrate with new displays, scanners, file formats, and browsers without resubmitting a 510(k) application. The web-based software is used for case and image management, slice image analysis, and collaboration among pathologists.

PathAI CEO Andy Beck said in a statement, "The 510(k) clearance underscores PathAI's commitment to quality and scientific rigor, providing a pathway forward as we continue to refine AISight Dx IMS."

The company stated that AISight Dx software provides integrated image management, synchronized multi-slide navigation, and powerful annotation tools, supporting faster and more consistent diagnoses.

AISight Dx software has been approved for use with Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners and has received CE certification under the European IVD Directive. The company announced nearly three years ago that its previous generation software, the AISight Dx (Novo) platform, had received 510(k) clearance and CE certification, and stated that the software could be used in the United States and the European Union with the Philips ultra-fast scanner.

PathAI also announced this month a collaboration with Northwestern Medicine in Chicago to apply AISight to 95 pathologists across 11 hospitals, and earlier this year, Brazilian healthcare network Rede D'Or said it would deploy AISight across its network of 78 hospitals.

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