August 4, 2017 Acad, Gov/Utilities

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

August 3, 2017 Acad, Gov/Utilities

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

July 31, 2017 Acad, Gov/Utilities Lab Top-10 Mass Spectrometry

Bruker Announces US FDA Clearance of Expanded 3rd Claim for MALDI Biotyper

BILLERICA, Mass., July 31, 2017 /PRNewswire/ — Bruker today announces that it has received US Food & Drug Administration (FDA) clearance for its third, further expanded claim for the market-leading MALDI Biotyper-CA (MBT-CA) system for fast, accurate and cost-effective microbial identification. The new claim includes a significant expansion of the microbial reference library for clinical... Read more

July 28, 2017 Acad, Gov/Utilities

FDA grants breakthrough therapy designation for Venclexta in acute myeloid leukaemia

Basel, 28 July 2017 FDA grants breakthrough therapy designation for Venclexta in acute myeloid leukaemia First in class BCL2-specific oral inhibitor represents a potential new way of treating acute myeloid leukaemia (AML), the most common type of aggressive leukaemia in adults1 17th breakthrough therapy designation for Roche’s portfolio of  medicines and 4th for Venclexta Roche... Read more

July 25, 2017 Acad, Gov/Utilities M&A, Partnerships

New England Biolabs joins EMBL’s Corporate Partnership Programme

Collaboration aims to strengthen training opportunities in the latest technologies for young researchers IPSWICH, Mass. and HEIDELBERG, Germany, July 25, 2017 /PRNewswire/ — The EMBL Advanced Training Centre (ATC) welcomes New England Biolabs (NEB®) as its newest member of their Corporate Partnership Programme. Founded in the mid-1970s as a collective of scientists committed to developing innovative products for the life... Read more

July 19, 2017 Acad, Gov/Utilities Clinical Research/Diagn. Microscopy PR/Corporate Product Launch

BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System

FRANKLIN LAKES, N.J., July 19, 2017 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™ flow cytometer system, an easy-to-use in vitro diagnostic (IVD) system, for use with BD Multitest™ assays... Read more