Significant news from Leica today — CE Mark in Europe for in-vitro diagnostics. With recent news from other manufacturers as well (see: Visiopharm and Omnyx) this news is significant for the digital pathology market and clearances in the US will soon be forthcoming!
VISTA, California, July 1, 2014 /PRNewswire/ — Leica Biosystems, a global leader in automation and workflow solutions for anatomic pathology, announced the registration of the Aperio AT2 high throughput digital slide scanner, as a CE-marked medical device for in vitro diagnosis (IVD) in Europe.
“The clinical clearance of the Aperio AT2 in Europe is another milestone in our ongoing commitment to provide complete solutions for healthcare professionals,” said Puneet Sarin, vice president and general manager, Leica Biosystems, Pathology Imaging. “This enables pathologists to diagnose from a computer screen. The integration with hospital and laboratory information systems provides a comprehensive platform for implementing digital pathology in routine diagnostics.”
The Aperio AT2 and ePathology software suite enables European healthcare institutions to leverage expert pathologists without the delays and logistics associated with shipping glass slides. Rapid access to eSlides, combined with optimal image quality from Leica Biosystems, enables pathologists to provide timely diagnoses to patients, which can help reduce the anxiety often associated with long turnaround times.
The Aperio AT2 extends the Leica Biosystems portfolio of brightfield and FISH clinical imaging and analysis solutions, which also includes the Aperio CS2 slide scanner and Ariol systems. To learn more about Aperio ePathology solutions and the Aperio AT2, please visithttp://www.LeicaBiosytems.com/Aperio.
About Leica Biosystems
Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomic pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica’s easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Further information can be found at LeicaBiosystems.com.
Category: Anatomic Pathology, Clinical Laboratories, Clinical Pathology, Device Manufacturers, Digital Pathology News, General Healthcare News, Histology, Informatics, International, Laboratory Compliance, Laboratory Informatics, Pathology News, Standards and Guidelines, Vendor products, Whole slide