Leica FL560 achieves First FDA Clearance for cerebrovascular fluorescence with fluorescein

View of an Arteriovenous Malformation (AVM) viewed with FL560 fluorescence. Photo courtesy of Cleopatra Charalampaki, MD, PhD, Professor of Neurosurgery, Department of Neurosurgery, Cologne Medical Center, Germany Leica Microsystems is proud to be the first company to attain FDA 510(k) clearance for its FL560 fluorescence microscope filter for visualization of cerebrovascular blood flow in conjunction... Read more

FDA grants Priority Review for Roche’s Gazyva in previously untreated follicular lymphoma

Basel, 28 August 2017 FDA grants Priority Review for Roche’s Gazyva in previously untreated follicular lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva... Read more

Free Webinar On-Demand: Basics in Component Cleanliness Analysis

For automotive manufacturers and auto parts suppliers, obtaining component cleanliness results rapidly, accurately, and reproducibly over the entire workflow is a significant advantage. Making it easier to build up facilities, knowledge and expertise in component cleanliness Pall and Leica can offer unique workflow solutions fitting to individual needs and compliant with common standards. Often for... Read more

Free Webinar On-Demand: Rate the quality of your steel

The quality of steel is an essential topic in automotive, metalworking and building industries. To ensure the highest standards, an accurate and reliable Quality Assurance workflow for the inspection of non-metallic inclusions is crucial. Leica Microsystems offers state-of-the-art and individualized microscopy solutions, allowing you to inspect the microstructure and evaluate the non-metallic inclusion content of... Read more

SIGNA Premier 510(k) Cleared by the US FDA

Waukesha, WI – August 4, 2017 – GE Healthcare (NYSE: GE) is proud to announce SIGNA™ Premier, a new wide bore 3.0T magnetic resonance imaging (MRI) system, is now available for sale in the U.S. SIGNA Premier is the result of a four-year collaboration with the National Football League (NFL) and research institutions around the world... Read more

FDA grants Roche’s Alecensa Priority Review for initial treatment of people with ALK-positive lung cancer

Basel, 03 August 2017 FDA grants Roche’s Alecensa Priority Review for initial treatment of people with ALK-positive lung cancer Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa® (alectinib) as an initial (first-line)... Read more