PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cerenion, Ecolab, Integrum, Occlutech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M Littmann Stethoscopes, Assure Tech, Aurora Spine, Bc Platforms, Beckman Coulter, Biosig Technologies, Bruker, Cerus Endovascular, Emurmur, Fulgent Genetics, Htg Molecular Diagnostics, Ingenion Medical, Inivata, Johnson & Johnson, Medsential, Misonix, Natera, Oncimmune, Paxman Coolers, Physiomics, Pra Health Sciences, Pwnhealth, Research Instruments, Roche, Tabula Rasa Healthcare.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EPA posts ethylene oxide rule on OMB agenda; HHS announces sustained support for testing; FTC gives nod to Stryker/Wright deal.
Keeping you up to date on recent developments in neurology, including: Research suggests SARS-CoV-2 enters the brain; Technique developed to predict seizures; Machine intelligence improves brain mapping research; Hearing, blood sugar linked to cognitive function among older Latinos.
In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Anitoa, Binx Health, Ellume, Exero Medical, Genetesis, Horiba, Roche, Seaspine, Switch Health.
