LEICA BIOSYSTEMS APERIO LV1 IVD APPROVED FOR REMOTE FROZEN SECTION AND TELEPATHOLOGY*
VISTA, CA – July 31st, 2018 – Leica Biosystems, the global leader in pathology workflow solutions, announced today that its live view telepathology system, the Aperio LV1 IVD, can now be used for on-screen diagnosis in Europe**, Canada, Australia and New Zealand.
This compact Digital Pathology system, with a capacity of 4 slides, navigates like a conventional microscope, but with a host of digital benefits. Live View with robotic controls enables real-time telepathology with remote access to slides in less than 15 seconds. It can also function as a low volume, whole-slide scanner, and its small footprint fits easily into limited laboratory space.
With In Vitro Diagnostic CE Mark, as well as Therapeutics Goods Administration (TGA) and Health Canada registrations, customers in Europe, Australia, New Zealand, and Canada can now use the Aperio LV1 IVD for diagnostic reads of frozen sections and regular FFPE histology slides.
“These registrations allow our customers to use the Aperio LV1 IVD for clinical diagnosis as part of their daily anatomic and surgical pathology workflows,” said Jerome Clavel, General Manager of Leica Biosystems Pathology Imaging business. “Real-time digital access to slides is critical for pathologists to provide remote frozen section consultations and slide reads from their office, or any other location.”
The clinical use claims described in the information provided have not been cleared or approved by the U.S. FDA nor are the products available in the United States.
About Leica Biosystems:
Leica Biosystems (LeicaBiosystems.com) is a global leader in workflow solutions and automation, integrating each step in the workflow. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries and is headquartered in Nussloch, Germany.
* Requires at least a 50 megabit per second (Mbps) internet connection using Team Viewer software (v10) and Aperio LV1 IVD console software (v4.0) with one slide loaded in the slide tray. 15 second time starts once the Team Viewer “Log On” is selected.
**Aperio LV1 IVD is now available in certain European countries only. Contact your Leica Biosystems representative for more information.