Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Globus Medical, Spectrum Solutions.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Eli Lilly, Exact Sciences, Genotests, Insulet, Jenavalve, Photocure, Thermo Fisher Scientific.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coopercompanies, Cytosorbents, Diacarta, Speedx, Syntr Health Technologies.
The FDA’s device center has generated a raft of warning letters for products related to the COVID-19 pandemic, and released another six such letters for the week of Aug. 9. However, the ostensible justification for those warnings varies considerably, as does the elapsed time between the date of the warning letter and its issuance on the FDA’s warning letter webpage.
Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Phase Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Asia Molecular Diagnostic Laboratory, Cardinal Health, China Biotech Services Holding, Empiramed, Fitbit, Fujifilm, Fujifilm Irvine Scientific, Happify Health, Life Whisperer, Lifescan, Oncxerna Therapeutics, Pillar Biosciences, Presagen, Pyramid Innovation, Qiagen, Quidel, Statlab Medical Products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qiagen, Spintech.
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