CE mark
MRC Holland Gains IVDR Certification for Spinal Muscular Atrophy Newborn Screening Test
The Amsterdam-based biotech firm said that its melt curve analysis-based test is used as a first-tier genetic screening tool to aid the diagnosis of SMA.
Aiosyn Gains CE-IVDR Mark for Breast Cancer Mitosis Counting Software
The Netherlands-based firm said that its Aiosyn Mitosis Breast software is used to aid tumor grading and provide a prognostic indicator to guide treatment decisions.
Bosch Bacterial Meningitis Molecular Test Nabs CE-IVDR Mark
The Vivalytic Bacterial Meningitis PCR test can detect six important bacterial meningitis pathogens in less than an hour from a cerebrospinal fluid sample.
Roche Nabs CE Mark for New Mass Spec System
The system includes the Cobas I 601 analyzer and the first Ionify reagent pack of four assays for steroid hormones.
Top Five Articles on 360Dx Last Week: Detact Dx Nabs Gates Awards; November FDA Clearances; More
Last week, readers were most interested in a story about Gates Foundation awards to Detact Diagnostics to further develop a POC system and assays to detect infectious diseases.