FDA Clears Leica Biosystems' Aperio GT 450 DX Digital Pathology System, Offering SVS and Native DICOM Compatibility

Monday, April 29, 2024

Leica Biosystems is excited to announce that its leading digital pathology system, the Aperio GT 450 DX, has received 510(k) clearance from the US Food and Drug Administration.

Previously available in the clinical market under enforcement discretion due to the COVID-19 pandemic, the Aperio GT 450 has demonstrated its reliability by consistently delivering high-quality images with a turnaround time of under 32 seconds per slide.

This is not the first time Leica Biosystems has introduced a regulated system; with 25 years of experience in the digital pathology field.

The company has been instrumental in implementing, integrating, and innovating technologies that have significantly impacted cancer diagnoses and patient outcomes.

Digital pathology is rapidly becoming essential in modern healthcare, transforming pathology laboratories worldwide. Pathology Informatics at Kaiser Permanente, Southern California. "Having implemented digital pathology within our group of over 100 pathologists, excited to be part of this transformative shift that is improving digital diagnostics and patient care."

General Manager of Digital Pathology at Leica Biosystems, emphasizes the importance of optimizing workflow with digital solutions in today's healthcare landscape.

"With digital pathology, clinicians can maintain high standards of quality, providing world-class images and fast turnaround times, ultimately delivering the best possible patient care despite resource limitations."



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