Big data can improve familial hypercholesterolemia screening October 23, 2019 -- A machine-learning algorithm may be useful for scanning electronic health records to spot people with undiagnosed familial hypercholesterolemia based on a mix of lab reports and other data, according to a study supported by big pharma and published in Lancet Digital Health on October 21. Discuss
Cheap vaginal-fluid testing signals risk for premature birth October 22, 2019 -- Low-cost testing of vaginal fluid could flag risk factors for preterm birth and could be useful at the point of care in resource-poor settings to reduce life-threatening complications, according to a study of pregnant women in Brazil published on October 22 in mBio, the journal of the American Society for Microbiology. Discuss
Ortho Sera extended blood typing clears FDA October 18, 2019 -- Ortho Clinical Diagnostics has announced the U.S. Food and Drug Administration (FDA) clearance of its Ortho Sera ID-Micro Typing System (MTS) extended antigen phenotyping in blood transfusion products, for use on the company's Ortho Vision analyzer.
FDA airs 'to do' list for devices in 2020 October 14, 2019 -- The U.S. Food and Drug Administration's (FDA) priorities for new guidance documents on medical devices in fiscal 2020 include updated recommendations for CLIA waiver applications for IVD device manufacturers, as well as updates for managing cybersecurity. Discuss
Insurance claims study makes case for more prenatal blood testing October 10, 2019 -- Some insurance companies restrict noninvasive prenatal testing to women who are older than 35 and have high-risk pregnancies. But testing also makes sense in younger pregnant women and can help decrease the use of amniocentesis and other invasive tests, according to a study presented on October 4. Discuss
FYR gets NIH small business grant for epilepsy diagnostics October 10, 2019 -- Privately held Montana startup FYR Diagnostics has been awarded a $334,000 grant, with the potential to rise to $618,000, from the U.S. National Institutes of Health (NIH) for research paving the way for the development of epilepsy diagnostics.