October 22, 2020 Acad, Gov/Utilities M&A, Partnerships Microscopy

St. Luke’s University Health Network Selects GE Healthcare for $11 Million Ultrasound Purchase to Create System-wide Efficiencies

(CHICAGO – October 22, 2020) GE Healthcare today announced its largest ever ultrasound deal in the United States – an $11 million order by St. Luke’s University Health Network to install GE Healthcare ultrasound technology and IT workflow solutions system-wide. GE Healthcare will continue upgrades over the next four years to maintain latest technology for... Read more

October 19, 2020 Acad, Gov/Utilities Bio/Pharma/CRO PAI Top-10

Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia

Approval supported by data from phase III confirmatory trials, VIALE-A and VIALE-C VIALE-A study showed Venclexta plus azacitidine significantly improved overall survival in newly diagnosed AML compared to azacitidine alone Supplemental New Drug Applications approved under the FDA’s Real-Time Oncology Review pilot programme and Project Orbis initiative              Basel, 19 October 2020 – Roche (SIX: RO,... Read more

October 12, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Microscopy PR/Corporate

GE Healthcare Receives FDA Clearance for Vivid Ultra Edition, AI-Powered Cardiovascular Ultrasound System Designed to Shorten Diagnostic Exam Time and Improve Measurement Consistency

Chicago (October 12, 2020) – GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid[1] cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious... Read more

October 5, 2020 Acad, Gov/Utilities Microscopy Product Launch

BD Granted FDA 510(k) Clearance for BD FACSLyric™ Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System

FRANKLIN LAKES, N.J., Oct. 5, 2020 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™ Flow Cytometer with the Integrated BD FACSDuet™ Sample Preparation System. The new integrated system enables clinical laboratories to fully automate... Read more

September 16, 2020 Acad, Gov/Utilities Bio/Pharma/CRO PAI Top-10 PR/Corporate

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs More... Read more

September 15, 2020 Acad, Gov/Utilities Environ, Ag./Food & Bev

GE Healthcare’s Clariscan™ (gadoterate meglumine) Becomes Only FDA-Approved MRI Contrast Agent Available in Polymer Bottle

US FDA approves +PLUSPAK™ (polymer bottle) Pharmacy Bulk Package for the gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine) As the only polymer bottle for an MRI contrast agent, Clariscan in +PLUSPAK offers the potential for increased workplace safety, efficiency, convenience and environmental advantages Clariscan has been approved in more than 65 countries globally, with more than... Read more

September 8, 2020 Acad, Gov/Utilities Clinical Research/Diagn. Lab Top-10 Life Science Tools

FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer

FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for GAVRETO CARLSBAD, Calif., Sept. 8, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a... Read more

September 8, 2020 Acad, Gov/Utilities Microscopy PR/Corporate

Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients

Immunocompromised transplant patients are at risk of major complications when infected with BK virus cobas BKV test addresses critical need for hospitals and laboratories to have standardised and comparable results across institutions New Breakthrough Device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK virus with Cytomegalovirus and Epstein-Barr virus... Read more

September 7, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer              Basel, 7 September 2020 – Roche (SIX:... Read more

September 4, 2020 Acad, Gov/Utilities Liq. Handling & Robotics Microscopy PR/Corporate

Roche receives FDA Emergency Use Authorization for the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems

First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients Test for use... Read more