All articles by Staff Writer
Staff Writer
Copan Diagnostics’ urine collection and transport device gains FDA clearance
The design of Copan’s urine collection device eliminates the need for precise fill lines or additional mixing, simplifying the preservation process.
QIAGEN Reaches Milestone With Over 1,000 Placements of EZ2 Connect Sample Preparation Instrument, Driving Laboratory Automation
QIAGEN today announced it has reached a significant milestone with over 1,000 placements of the EZ2 Connect automated sample preparation instrument, an advancement of the EZ1 instrument line.
QIAGEN Strengthens QIAstat-Dx With New Barcelona Site to Drive Growth in Infectious Diseases and Precision Medicine Testing
BARCELONA, Spain & VENLO, the Netherlands–(BUSINESS WIRE)– QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to move its QIAstat-Dx operations within the Barcelona area to a new site in Esplugues de Llobregat as part of a multi-year investment to strengthen this business.
BD to acquire Edwards Lifesciences’ Critical Care unit for $4.2bn
The sale will allow Edwards Lifesciences to focus on structural heart disease technologies.
ELITechGroup achieves a new CE-IVDR Certification
ELITechGroup is pleased to announce that they have obtained the IVDR certification for four new products including the brand new CMV RNA ELITe MGB Kit.
Thermo Fisher Scientific Unveils New Solutions Supporting Research Workflows at ASMS 2024
New analytical instruments and workflow capabilities improve productivity, reliability and sensitivity of discovery, translational and clinical research.
FDA approves IDE for Early Feasibility Study of CorTec’s Closed-Loop Brain Interchange implant system
CorTec has announced today that the US Food and Drug Administration (FDA) has approved an
Investigational Device Exemption (IDE) application by the University of Washington School of
Medicine (UW) involving the closed-loop Brain Interchange Implant System. This clinical study will
investigate a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity
within the brain. With the clearance of the Brain Interchange System for human use CorTec is
prepared to serve clinicians and research groups with its advanced implant technology to
investigate novel treatment options for neurological diseases.
bioMérieux receives FDA clearance of VIDAS® TBI (GFAP, UCH-L1)
bioMérieux receives FDA 510(k) clearance of VIDAS® TBI (GFAP, UCH-L1), an innovative test to improve the assessment of patients with mild traumatic brain injury
Thermo Fisher Scientific Opens New GMP-certified Ultra-cold Facility in the EU
The new facility in Bleiswijk, Netherlands offers a comprehensive range of cold and ultra-cold services enabling global clinical trial innovation and biorepository storage solutions
QIAGEN expands QIAstat-Dx syndromic testing menu in US
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States. The launch comes after the recent clearance of the syndromic test for clinical use by the U.S. Food and Drug Administration (FDA) and marks a significant step forward in improving the accuracy and efficiency of gastrointestinal (GI) infection diagnosis.