VISTA,
Calif., April 29, 2024 /PRNewswire/ -- Leica
Biosystems is pleased to announce that its flagship digital
pathology system, Aperio GT 450 DX, has received 510(k) clearance
from the US Food and Drug Administration. Previously sold into the
clinical market under an enforcement discretion due to the COVID-19
pandemic, Aperio GT 450 is proven technology that consistently
delivers high-quality images at a fast turnaround time of < 32
sec/slide.
Aperio GT 450 DX is not Leica Biosystems first regulated system:
the company has 25 years of experience implementing, integrating,
and innovating in the digital pathology space, enabling clinicians
to advance their cancer diagnoses and improve lives.
"Digital pathology is rapidly emerging as the cornerstone of
modern healthcare, revolutionizing the field of pathology as
laboratories across the globe embrace this transformative
technology," said Dr. Sony Wirio, Regional Chief Pathologist and
Director of Pathology Informatics at Kaiser Permanente,
Southern California. "Drawing from
our extensive experience in implementing digital pathology within
our group of over 100 pathologists, we are excited to be a part of
this groundbreaking shift that is shaping digital diagnostics and
enhancing patient outcomes."
"There is no better time for laboratories to optimize their
workflow with digital," said Naveen
Chandra, Vice President and General Manager of Digital
Pathology at Leica Biosystems. "Today, clinicians are faced with
having to do more with less – digital pathology enables them to
maintain a high standard of quality with world class images and a
fast turnaround time, for the best patient care possible."
About Leica Biosystems:
Leica Biosystems is a cancer diagnostics company and a global
leader in workflow solutions. The company offers a comprehensive
product range for each step in the pathology process, from sample
preparation and staining to imaging and reporting. As the only
company to own the full workflow from biopsy to diagnosis, Leica
Biosystems is uniquely positioned to break down the barriers
between each step. The company's mission of "Advancing Cancer
Diagnostics, Improving Lives" is at the heart of its corporate
culture.
Media Contact:
Lauren Meinhardt
657-226-6970
lauren.meinhardt@leicabiosystems.com
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SOURCE Leica Biosystems