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

May 18, 2020 Acad, Gov/Utilities Lab Top-10 PAI Top-10

Thermo Fisher Scientific's Support of COVID-19 Response Continues to Expand with U.S. Government Contract for Products Used in Sample Collection

Thermo Fisher Scientific’s Support of COVID-19 Response Continues to Expand with U.S. Government Contract for Products Used in Sample Collection WALTHAM, Mass., May 18, 2020 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it has received a contract from the U.S. government to provide highly specialized viral transport... Read more

May 14, 2020 Acad, Gov/Utilities Atomic Spectroscopy Lab Top-10

Helios 5 Laser PFIB Accelerates the Pace of Materials Research for Academic and Industrial Users

Helios 5 Laser PFIB Accelerates the Pace of Materials Research for Academic and Industrial Users First-of-its-kind commercial solution analyzes 3D and sub-surface data 15,000 times faster than a typical Ga-FIB HILLSBORO, Ore., May 14, 2020 /PRNewswire/ — Thermo Fisher Scientific today released the Thermo Scientific Helios 5 Laser PFIB system, an advanced focused ion beam... Read more