HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Endospan, Fosun Pharma, Foundation Medicine, Genosensor, Osang Healthcare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cirrusdx, Curative, Vent Multiplexor.
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
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