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. Read More

Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians. Read More

Sonalasense Inc., a company working in the field of sonodynamic therapy, is collaborating with the Ivy Brain Tumor Center at Barrow Neurological Institute to conduct a first-in-human clinical trial of its noninvasive sonodynamic therapy for the treatment of recurrent glioblastoma multiforme (rGBM). The sonodynamic platform technology uses a dual approach with aminolevulinic acid (ALA) and MRI-guided focused ultrasound to target glioblastoma cells for destruction. Read More

Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis. Read More

PARIS – Braintale SAS has completed a $1.2 million seed round towards its portfolio of digital quantification and prediction medical devices for neurology and intensive care. This funding round, including a loan from Bpifrance, attracted investment from business angels, as well as industry and health care professionals. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG seeks comment on safe harbors. Read More

New hires and promotions in the med-tech industry, including: Irhythm Technologies, Neurocytonix, Pelvital, Tissium. Read More

Med-tech firms raising money in public or private financings, including: Brain Scientific, Nference, Ocular Therapeutix, Singlera Genomics, Viewpoint Molecular Targeting. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biodesix, Medtronic, Numares. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acist Medical Systems, Ambu, Baylis Medical, Bw-Tec, Corindus Vascular Robotics, Corvent Medical, Ekpac Healthcare, Genscript Biotech, Glytec, Innobation, Johnson & Johnson, Mauna Kea Technologies, Machine Solutions, Medis Medical Imaging, Oxford Nanopore Technologies, Sensorion, Sensyne Health, Siemens Healthineers, Sonova Holding, Sourcebio International, Takeda Pharmaceutical, Telix Pharmaceuticals, Thinkgenetic, Veracyte. Read More

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. Read More

Keeping you up to date on recent developments in oncology, including: Study clarifies distinct genomic features of early-onset appendiceal cancer; MET no better than EMT for cancer metastases; MRI may offer risk-stratification for glioblastoma; Study supports short telomeres as protective against cancer. Read More