The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allscripts, Aposhealth, Caredx, Casa Schmidt, Centene, Henry Schein, Integra Lifesciences, Magellan Health, Nextgen Biomed, Scent Medical Technologies, Si-Bone, Smith & Nephew, Virtue Health, Wellsky.
Keeping you up to date on recent developments in cardiology, including: Researchers outline new stroke strategy; Group assesses role of neutrophil extracellular traps in coronary thrombosis in COVID-19 patients; Link identified between metabolic syndrome and higher cardiovascular risk in patients with psoriasis.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Antengene, Arcturus, Atara, Ayala, Bioniz, BMS, Forge, Inozyme, Matinas, Opko, Passage, Pfizer, Provention.
Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.
The U.S. FDA has granted emergency use authorization (EUA) to Quanterix Corp.’s SARS-CoV-2 IgG antibody test, which tests blood samples for evidence of recent or prior COVID-19 infection. The test could also be used to measure antibody response to a COVID-19 vaccine. The Simoa Semi-Quantitative SARS-CoV-2 IgG antibody test is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma from a venous blood draw.
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