As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
BEIJING – Biotech companies in China were among the first to experience disruptions in their operations and development plans from the COVID-19 outbreak, with employees unable to report to work and difficulties continuing trials.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Neural Fiber Optic Systems, Medx Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Extracts, Arima Genomics, Asuragen, Aytu Bioscience, Becton, Dickinson and Co., Biogx, Blue Earth Diagnostics, Bracco Imaging, Caredx, Cefaly, Co-Diagnostics, Datos, Geacom, Haselmeier, Healthcall, Heiq Materials, IDbyDNA, Illumina, Impulse Dynamics, Invo Bioscience, Nobio, Pharmajet, Qiagen, Roche, Supergum, Tandem Diabetes Care, Twist, West China Hospital, XCR Diagnostics.
“We look forward to the day where we can get back to normal,” U.S. President Donald Trump said Monday at a COVID-19 news conference in which reporters sat every-other-seat apart. In an unusually somber tone, the president said it now looks like it will be at least July or August before the outbreak “washes through.”
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