Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV technology for use in COVID-19 treatment.
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.
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.
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).
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.”
The collection of nasal and throat swab samples to detect the presence or absence of the novel coronavirus SARS-CoV-2 has proven problematic on a few fronts, particularly in the U.S. The swabs themselves often have become scarce and difficult to obtain, while health care workers are routinely risking their own health commonly in the absence of proper protective equipment. In addition, sampling difficulties have largely been blamed for a very high false negative rate that could be as much as 25%.
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.