Category: Acad, Gov/Utilities
FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
Basel, 06 May 2019 FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment The approval is based on data showing Kadcyla cut the risk of disease recurring by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast... Read more
BD Receives FDA Approval for Fully Sterile Chlorhexidine Gluconate Antiseptic Skin Preparation
FRANKLIN LAKES, N.J., April 30, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) approval for BD ChloraPrep™ skin preparation with sterile solution, the only fully sterile chlorhexidine gluconate (CHG) antiseptic skin preparation commercially available in the... Read more
Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy
Basel, 23 April 2019 Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed... Read more
Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC
Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC PD-L1 IHC 22C3 pharmDx Can Now Be Used to Identify a Broader Range of NSCLC Patients for First-line Treatment With KEYTRUDA® (pembrolizumab) SANTA CLARA, Calif., April 16, 2019 Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has... Read more
Bruker and the Translational Metabolic Laboratory at Radboud University Medical Center Announce the Establishment of a Joint Center of Excellence for Translational Omics
Nijmegen, Netherlands, April 16, 2019 – At the opening event of the Netherlands X-omics Initiative, Bruker and the Translation Metabolic Laboratory (TML) at Radboud University Medical Center (UMC) today jointly announce the establishment of a Center of Excellence (CoE) for Translational Omics. Under the leadership of Professor Alain van Gool, the joint CoE will focus on... Read more
GE Healthcare Accelerates AI Model Development and Deployment with Launch of Edison Integration to American College of Radiology AI-LAB™
Boston, MA – April 8, 2019 – GE Healthcare today announced Edison will integrate with ACR AI-LAB. The Edison platform helps accelerate the development and adoption of Artificial Intelligence (AI) technology and empower providers to deliver faster, more precise care. Edison serves as a “digital thread” for GE Healthcare’s existing AI partnerships and products, and... Read more
QIAGEN launches first FDA-approved companion diagnostic using FGFR alterations to help guide the treatment of metastatic urothelial cancer
Germantown, Maryland, and Hilden, Germany, April 12 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its novel therascreen® FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic to help guide the use of the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib), developed by Janssen Biotech,... Read more
Handheld Raman Analyzer from Rigaku Analytical Devices Chosen as Part of U.S. Department of Defense Tech Refresh Program
The Rigaku Progeny ResQ 1064 nm handheld Raman analyzer will be deployed globally as part of the U.S. Army’s Dismounted Reconnaissance Sets, Kits, and Outfits (DRSKO) Program Wilmington, MA (April 2, 2019) – Rigaku Analytical Devices, a U.S.-based, leading pioneer of handheld and portable spectroscopic analyzers, is pleased to announce they will provide the Rigaku... Read more
New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories
New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories Thermo Scientific Medical Device portfolio provides an extensive range of chromatography and mass spectrometry instruments for laboratory development test optimization PALM SPRINGS, Calif., April 1, 2019 /PRNewswire/ — MSACL US 2019 – Thermo Fisher Scientific announces the expansion of its portfolio... Read more