The U.S. FDA has rewritten the emergency use authorization (EUA) for the Laboratory Corp. of America Holdings Inc. (Labcorp) COVID-19 polymerase chain reaction (PCR) test to allow for diagnostic testing of those who are asymptomatic and those who have no reason to suspect they are infected with the SARS-CoV-2 virus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Fortress Diagnostics, Lemaitre Vascular, MedPAC.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Color, Labcorp, Rapid Medical, Stratus Medical, Zebra Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atox, Bruker, Cell and Gene Therapy Catapult, Cpi, Healthimation, Masimo, Microfluidx, Nanthealth, Nemaura, OpenNMS, Orcam, Perimeter Medical Imaging, Telix Japan, Transenterix, Wishbone Medical.
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases.
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