The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.
Health care professionals (HCPs) might prefer a new respirator for each shift, but the ongoing shortage has left clinical sites with a need to employ dry heat for filtering facepiece respirator reuse. The U.S. FDA said on a Jan. 26 town hall that it will stick to an established policy that these devices can be processed with dry heat no more than five times, a practice that is likely to stick for the foreseeable future despite that administrators are required to provide fresh units when possible.
PERTH, Australia – Sydney-based Cyclopharm Ltd. raised AU$30 million (US$23.19 million) in a private placement that will enable the company to launch its Technegas combination product in the U.S.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asieris, Bc Platforms, Chronomics, Curadigm, Dante Labs, Digbi Health, Echosens, Electrocore, Emocha, Fuzionaire Radioisotope Technologies, Gastrologix, Genedx, Nanobiotix, Nihon Medi-Physics, Nova Mentis Life Science, Orasure, Opko Health, Perkinelmer, Photocure, Qualigen, Sanofi, Soliton, Soundbite, Yi Xin.
In signing an executive order (EO) on strengthening American manufacturing Jan. 25, President Joe Biden made it clear that the order is aimed at more than infrastructure. While Biden’s Build Back Better Recovery Plan calls for investing hundreds of billions of dollars in buying American products and materials to modernize the nation’s infrastructure and increase its competitiveness, “it also means replenishing our stockpiles to enhance our national security,” the president said.
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed urges administration to communicate on DPA; FDA posts third-party report for Q1, FY 2021.
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