Leica Biosystems proudly announces the FDA’s 510(k) clearance for its flagship digital pathology system, the Aperio GT 450 DX. Previously utilized under enforcement discretion due to the pandemic, this technology now stands recognized for its exceptional performance in clinical settings. With a rapid turnaround time of less than 32 seconds per slide, the Aperio GT 450 DX consistently produces high-quality images.
This clearance marks another milestone in Leica Biosystems’ 25-year journey of pioneering advancements in digital pathology. Their expertise spans implementation, integration, and innovation, empowering clinicians worldwide to enhance cancer diagnoses and patient outcomes.
Dr. Sony Wirio, Regional Chief Pathologist at Kaiser Permanente, Southern California, praises the transformative impact of digital pathology on healthcare. Drawing from their extensive experience, they highlight the pivotal role of digital diagnostics in improving patient care.
Naveen Chandra, Vice President of Digital Pathology at Leica Biosystems, emphasizes the timeliness of adopting digital solutions in laboratories. Amidst increasing demands and resource constraints, digital pathology ensures clinicians can maintain superior standards without compromising efficiency. Leica Biosystems distinguishes itself as a cancer diagnostics company and a global leader in workflow solutions. With offerings spanning sample preparation, staining, imaging, and reporting, they own the entire pathology process, streamlining workflows and improving diagnostic accuracy. Rooted in their mission of “Advancing Cancer Diagnostics, Improving Lives,” Leica Biosystems is committed to driving innovation and breaking down barriers in cancer care.