All articles by Staff Writer
Staff Writer
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.
BD to acquire Edwards Lifesciences’ Critical Care unit for $4.2bn
The sale will allow Edwards Lifesciences to focus on structural heart disease technologies.
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.
QIAGEN enhances bioinformatics workflows with new secondary analysis solution for oncology and inherited disease applications
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the availability of QCI Secondary Analysis, a cloud-based software-as-a-services (SaaS) solution enabling high-throughput secondary analysis for use with any clinical next-generation sequencing (NGS) data.
Bruker Completes Acquisition of Molecular Diagnostics Innovator ELITech
Bruker Corporation (Nasdaq: BRKR) is pleased to announce the closing of its acquisition of ELITechGroup (“ELITech”) for €870 million in cash, excluding the carved out ELITech clinical chemistry business. ELITech is a differentiated, fast growing and profitable provider of systems and assays for molecular diagnostics (MDx), biomedical systems/specialty IVD, and microbiology, with FY 2023 revenue of approximately EUR 150 million, and more than 80% consumables revenue.
Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB
AUD 17 Million Grant over 5 Years Will Fund Next-Generation TB Cures