Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Binx Health, Cerus Endovascular, Nines, Refine USA, Rheonix, Synaptive Medical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Helius Medical Technologies, Sigrid Therapeutics, Xenex.
Artificial intelligence-focused Chronolife SAS, of Paris, has secured class IIa medical certification from the EU for its smart T-shirt, which has the new brand name Keesense. The reusable, washable T-shirt is designed for comfortable, round-the-clock use. It works by transmitting data to a paired smartphone app via Bluetooth.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diatherix, Medtronic, Photopharmics, Psychemedics, Senseonics, Vuno.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Bioiq, Canon Medical Systems, Centene, Current Health, Dexcom, DFP Healthcare Acquisitions, ELT Sight, Intersystems, Labcorp, Masimo, Matrix Medical Network, Mayo Clinic, Medable, Medical Diagnostic Laboratories, Medplace, Mindray, Proteogenix, Pure Health, Quest Diagnostics, Seasun, Soc Telemed, Tmk Manufacturing, Trinity Health, Vander-Bend, Windtree.
Keeping you up to date on recent developments in orthopedics, including: Physio support in COVID-19 recovery; Co-delivery of IL-10 and NT-3 to enhance spinal cord injury repair; European countries face a costly 23% increase in fragility fractures by 2030.
The Trump administration has posted an update to its plan to reopen the U.S. economy, this time with a slightly different twist on testing. This plan not only calls on local governments to administer tests for the SARS-CoV-2 virus, but also calls for two antibody tests per person under some circumstances, an approach that should beef up both the positive and negative predictive values compared to a single antibody test.
Reports of unusually high death rates for COVID-19 patients on ventilators have raised alarms, and some doctors are looking to reduce reliance on the breathing machines when possible. To advance that goal, Lungpacer Medical Inc., of Vancouver, British Columbia, has obtained an emergency use authorization (EUA) from the U.S. FDA for its Lungpacer diaphragmatic pacing therapy system (DPTS) for immediate use in ventilator patients at high risk of weaning failure, including patients with the novel coronavirus.
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