Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES). The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx. Read More
The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time. Read More
Researchers at the Feinstein Institutes for Medical Research, the research arm of New York-based Northwell Health, have developed a noninvasive method for targeting stimulation of the vagus nerve. Vagus nerve stimulation (VNS) offers promise for treatment of a wide range of conditions, given the nerve's extensive involvement in regulating many organs, but has been constrained by adverse effects caused by off-target activation of fibers. Read More
LONDON – French venture capital firm Kurma Partners has announced the first closing at €50 million (US$58.6 million) of its second fund to be wholly devoted to seed and early stage investment in diagnostics. Kurma Diagnostics 2 (KDx2) will be invested in molecular and digital diagnostics technologies being spun out of universities and research centers across Europe, backing a total of 15 companies. Read More
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north. Read More
An international research team has identified a bacterial/viral combination more likely to be present in children with postinfectious hydrocephalus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dascena, Labcorp, OralDNA Labs. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Rockefeller Foundation. Read More
Keeping you up to date on recent developments in neurology, including: Social isolation increases anxiety and asymmetry in brain atrophy in AD; Researchers test brain stimulation in zero gravity; Angiotensin inhibitors for AD prevention. Read More
