Marinus Pharmaceuticals Inc.’s GABAA receptor agonist Ztalmy (ganaxolone), has won U.S. FDA approval for treating seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.
At this year’s Healthcare Information and Management Systems Society (HIMSS) 2022 conference in Orlando, Fla., digital health companies across the sector gathered to showcase new products and services. HIMSS CEO Hal Wolf urged the industry to focus on global health equity and a 2022 survey of health care leaders highlighted the elements of digital transformation that are causing the biggest buzz.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amolyt, Aquestive, Bioheng, Heron, Inflarx, Moderna, TC, Tetra.
Royal Philips NV has been handed a health care policy order requiring it to recall and replace 277,500 defective respiratory therapy devices in France within four months. Twelve ranges of respiratory device for patients who depend on mechanical breathing assistance as well as continuous positive airway pressure devices used to treat sleep apnea, have been affected by a design issue.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adagene, Aim Immunotech, Biontech, Brii, Iovance, Kaléo, Ossium Health, Pfizer, Shionogi, Sonnet, The AIDS Clinical Trials Group.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Minute Molecular Diagnostics.
The FDA unloaded on Neurofield Inc. for misbranding of its products, which are only approved as class II biofeedback devices, as neurostimulation and electroencephalogram (EEG) signal processing devices. The warning letter called on “Neurofield to cease any activities that result in the adulteration or misbranding of the Neurofield X3000/X3000 Plus, Neurofield Q21, Neurofield64 and Neurofield EEG.”
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Orthofix Medical.
RSS
