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In Vitro Diagnostics News

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1-15 of 2943 results
BD offers diagnostic solutions to combat antimicrobial resistance
Becton, Dickinson and Company (BD), a global medical technology company, has announced the global distribution of a complete portfolio of products for mass spectrometry that provides high-speed and high-confidence identification of pathogens in clinical laboratories.
Diagnostics > In Vitro Diagnostics > News
GenMark gets CE mark for ePlex blood culture identification fungal pathogen panel
GenMark Diagnostics has secured CE Mark under the European In‐Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex blood culture identification fungal pathogen (BCID-FP) panel.
Diagnostics > In Vitro Diagnostics > News
Abbott's acquisition of Alere to go ahead at reduced price
By MDBR Staff Writer
Healthcare firm Abbott has amended the existing agreement to acquire diagnostic device and services provider Alere.
Diagnostics > In Vitro Diagnostics > News
FDA approves Roche’s CINtec histology test to diagnose cervical disease in women
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Roche’s CINtec histology test to diagnose cervical disease in women.
Diagnostics > In Vitro Diagnostics > News
Genedrive submits Hepatitis C test for CE Marking certification
By MDBR Staff Writer
Molecular diagnostics firm Genedrive has submitted its hepatitis C test, the Genedrive HCV ID Kit, for CE marking certification in the European Union.
Diagnostics > In Vitro Diagnostics > News
Beckman Coulter Diagnostics gets FDA clearance for DxC 700 AU chemistry analyzer
By MDBR Staff Writer
Beckman Coulter Diagnostics has announces FDA clearance and US commercial launch of its new DxC 700 AU chemistry analyzer.
Diagnostics > In Vitro Diagnostics > News
Courtagen launches new Spotlight gene tests for neuromuscular disorders
Courtagen Life Sciences has launched 10 new gene panels in its Spotlight line of tests.
Diagnostics > In Vitro Diagnostics > News
Chiesi Farmaceutici, Molecular Warehouse to develop diagnostic tool for transplant patients
By MDBR Staff Writer
Chiesi Farmaceutici has collaborated with Molecular Warehouse to develop novel diagnostic system, which will allow transplant patients to remotely monitor their immunosuppressant levels.
Diagnostics > In Vitro Diagnostics > News
Accelerate Diagnostics gets FDA marketing authorization for Accelerate Pheno system
Accelerate Diagnostics has announced that the US Food and Drug Administration has granted the de novo request to market the Accelerate Pheno system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples.
Diagnostics > In Vitro Diagnostics > News
Immunexpress gets FDA approval for SeptiCyte LAB to differentiate sepsis patients
Immunexpress has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of SeptiCyte LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of ICU admission.
Diagnostics > In Vitro Diagnostics > News
MDBR Interviews Harry Glorikian About the Growing Significance of In Vitro Diagnostics
Sharing his insight with MDBR, Glorikian discusses the recent release of his report, Commercializing Novel IVDs: A Comprehensive Manual for Success, and the role of in vitro diagnostics (IVD) today.
Diagnostics > In Vitro Diagnostics > News
Cepheid wins FDA clearance for Xpert Xpress Flu and Xpert Xpress Flu/RSV
Cepheid has received clearance from the US Food and Drug Administration (FDA) to market Xpert Xpress Flu and Xpert Xpress Flu/RSV.
Diagnostics > In Vitro Diagnostics > News
Ovid Therapeutics, NeuroPointDX collaborate to identify biomarkers for Angelman Syndrome
Ovid Therapeutics and NeuroPointDX have entered into a collaboration to identify novel biomarkers of Angelman syndrome by analyzing metabolomic profile data as part of Ovid’s ongoing randomized, double-blind, placebo-controlled Phase 2 clinical trial (STARS).
Diagnostics > In Vitro Diagnostics > News
Meridian’s Bioline introduces new JetSeq DNA library preparation kits
By MDBR Staff Writer
Meridian Bioscience subsidiary Bioline has expanded its JetSeq DNA library preparation portfolio for next generation sequencing (NGS) sample preparation.
Diagnostics > In Vitro Diagnostics > News
Researchers create MAGIC algorithm to predict bone marrow transplant patients' risk of dying
By MDBR Staff Writer
Researchers from the Mount Sinai Health System have developed a new test to predict whether bone marrow transplant patients may die from common complication.
Diagnostics > In Vitro Diagnostics > News
1-15 of 2943 results