Leica Biosystems has expanded its FDA-cleared digital pathology lineup with a fresh set of 510(k) approvals. The flagship addition is software the Danaher company says is the first AI-assisted quality control tool cleared on its own for clinical labs.
The clearances cover Aperio iQC DX software, which spots artifacts in whole slide images introduced during tissue preparation, staining, coverslipping or scanning, such as air bubbles and pen marks. Catching those defects automatically lets labs release high-quality digital slides faster, an increasingly important edge as case volumes and diagnostic complexity climb.
Leica also added the Aperio GT 180 DX scanner to its cleared lineup and upgraded capabilities on the Aperio GT 450 DX scanner. Together the tools aim to push laboratories beyond simple digitization toward connected, standardized and scalable clinical workflows.
The FDA wins land as pathology labs face staffing pressure and growing cancer case loads. Digital pathology has become a proving ground for medical AI, with regulators clearing an accelerating stream of software that assists pathologists rather than replacing them.
For Leica, the clearances strengthen its position against competitors racing to pair scanners, software and AI services into end-to-end offerings that speed cancer diagnoses.
