Acad, Gov/Utilities Archives - Page 20 of 54

June 15, 2020 Acad, Gov/Utilities

GE Healthcare to collaborate with University of Oxford, NCIMI on AI algorithms to help predict COVID-19 severity, complications and long-term impact

Chalfont St Giles, UK – June 15 2020 GE Healthcare is working with the University of Oxford-led National Consortium of Intelligent Medical Imaging (NCIMI) in the UK to develop and test algorithms to aid in the diagnosis and management of COVID-19 pneumonia. The program will focus on developing, enhancing and testing potential algorithms to help... Read more

PerkinElmer Receives FDA Emergency Use Authorization for EUROIMMUN COVID-19 RT-PCR Test

Company’s latest FDA EUA solution broadens RT-PCR and serology offerings available in the U.S. WALTHAM, Mass. – June 15, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that EUROIMMUN, a PerkinElmer Company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for... Read more

June 15, 2020 Acad, Gov/Utilities Lab Top-10

FDA Grants Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients

FDA Grants Breakthrough Device Designation to Thermo Fisher Scientific’s Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients Designation follows recent announcement on development of first companion diagnostic using the Oncomine Precision Assay on the new Ion Torrent Genexus System CARLSBAD, Calif., June 15, 2020 /PRNewswire/ — The U.S. Food and Drug... Read more

June 10, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Environ, Ag./Food & Bev Life Science Tools PR/Corporate

Illumina Receives First FDA Emergency Use Authorization for a Sequencing-Based COVID-19 Diagnostic Test

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) is paving the way for large-scale, next-generation sequencing-based (NGS) COVID-19 testing. Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options... Read more

June 9, 2020 Acad, Gov/Utilities PR/Corporate

GE Healthcare Receives FDA Clearance of the Industry’s First Contrast-Enhanced Mammography Solution for Biopsy

Chicago, Illinois – June 9, 2020 – To help empower clinicians and patients in their fight against breast cancer, GE Healthcare today announced the Food and Drug Administration’s 510(k) clearance of Pristina Serena Bright™*, the healthcare industry’s first contrast-enhanced mammography solution for https://www.genewsroom.com/press-releases/ge-healthcare-receives-fda-clearance-industry%E2%80%99s-first-contrast-enhanced-mammography Read more

June 8, 2020 Acad, Gov/Utilities Lab Top-10

Thermo Fisher Extends NanoDrop One/OneC Spectrophotometer to FDA-Regulated Companies

Thermo Fisher Extends NanoDrop One/OneC Spectrophotometer to FDA-Regulated Companies New software can be used by pharma, biotech labs to comply with Title 21 CFR Part 11 data integrity regulations HILLSBORO, Ore., June 8, 2020 /PRNewswire/ — Thermo Fisher Scientific today announced its Thermo Scientific NanoDrop PC Control software + Security Suite for NanoDrop One/OneC can be... Read more

June 4, 2020 Acad, Gov/Utilities PR/Corporate

Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorisation to help in identifying patients at high risk of severe inflammatory response

FDA EUA1 now makes IL-6 testing accessible to patients in the United States to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark2 Interleukin 6 (IL-6) is an early indicator for acute inflammation to aid in the management of critically ill patients This test... Read more

June 2, 2020 Acad, Gov/Utilities

FDA approves Roche’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot programme Basel, 2 June 2020... Read more

May 27, 2020 Acad, Gov/Utilities

Shorter Scans and Better Image Quality: Deep Learning-Based MR Image Reconstruction Tech from GE Healthcare now FDA Cleared

Waukesha, WI – May 27, 2020 – GE Healthcare today announced U.S. FDA 510(k) clearance of AIR Recon DL. This pioneering technology, using a deep learning-based neural network, improves the patient experience through shorter scan times while also increasing diagnostic confidence with better image quality across all anatomies. AIR Recon DL, developed on GE Healthcare’s... Read more

May 19, 2020 Acad, Gov/Utilities

FDA approves Roche’s Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer

Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the US Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy Basel, 19 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)... Read more