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Author Archives: Kristen

Inspirata buys digital pathology company Omnyx

Feb. 13, 2018—Inspirata, a biotechnology and software company, announced it has acquired Pittsburgh-based Omnyx from GE Healthcare. Omnyx’s flagship digital pathology software, Dynamyx, aims to enhance the pathology workflow by providing new channels for collaboration and tools to boost efficiency. The software is CE-marked in Europe and licensed by Health Canada for in vitro diagnostic use. “The acquisition of Omnyx ...

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Alcor Scientific’s iSED at the Winter Olympics

Feb. 9, 2018—Alcor Scientific announced its iSED Analyzer will be used by the laboratory at the Korean Medicine Center at the Pyeongchang 2018 Olympic Winter Games and Paralympic Winter Games. The iSED is a fully automated erythrocyte sedimentation rate analyzer that analyzes red blood cells to diagnose bacterial infections and inflammation as well as to monitor patients’ responses to medications ...

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Advanced Instruments single-sample osmometer

Feb. 8, 2018—Advanced Instruments announced its Osmo1 Single-Sample Micro-Osmometer. It is suited for clinical laboratories that directly draw and test small sample volumes and was designed specifically to improve efficiency and reduce sample turnaround time. The instrument measures the osmolality of body fluids, such as whole blood, serum, plasma, urine, feces, sweat, and tissue homogenate, using the freezing point depression ...

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FDA: Rethink how diagnostics are regulated

Feb. 6, 2018—U.S. Food and Drug Administration commissioner Scott Gottlieb, MD, said we need to think differently about how we regulate diagnostics. “It’s been a little bit more challenging to define a pathway on how to get regulatory approval for the diagnostic at the same time you get regulatory approval for the drug, in part because a lot of these ...

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Siemens lands FDA clearance for BUN, TC02 tests

Feb. 1, 2018—Siemens Healthineers announced today it received 510(k) clearance from the FDA for its blood urea nitrogen (BUN) and total carbon dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances. Siemens can now provide a full menu on a single test card within the blood analysis market for clinicians to perform at the ...

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Sciex launches high-performance MS/MS system

Jan. 31, 2018—Sciex Diagnostics announced the launch of the Citrine Triple Quad MS/MS and Citrine Qtrap MS/MS Systems for clinical diagnostics. The Citrine MS/MS system enables the measurement of trace levels of biomarkers and metabolites at sub-pg/mL concentrations, comprehensive multianalyte panels, and the measurement of large and small molecules. Qtrap technology enables workflows that provide quantitative and qualitative analysis in ...

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Aptima HBV Quant Assay gets PMA approval

Jan. 30, 2018—Hologic announced the FDA has granted PMA approval for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the Panther system. The Aptima HBV Quant assay is the newest addition to the Panther system’s viral load menu, joining the previously approved Aptima HIV-1 Quant Assay and Aptima HCV Quant Dx Assay. The three assays ...

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