The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.
Stony Brook Medicine has launched an FDA-approved, randomized investigational new drug (IND) trial to determine whether plasma from people who have recovered from COVID-19 can aid in the recovery of patients currently fighting the disease. Chembio Diagnostics Inc.'s COVID-19 rapid serological point-of-care test will be used to identify potential plasma donors.
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Johnson & Johnson, Takeda Pharmaceutical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch Therapeutics, Cytosorbents.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Endosurgery, Atricure, Eos imaging, Kolon Tissuegene, Piranha Medical, Pluristem, Predictive Biotech, Predictive Technology, Rethink My Health, Scworx, Shockwave Medical, Staar Surgical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allen Technologies, Alphatec Holdings, Auburn University, Avacta Group, Biobot Analytics, Biodesix, Chembio Diagnostics, Cryo Innovations, Cytiva, Genomoncology, Hai Kang, HPC-AI, Integra Lifesciences, Intuitive, JMA, Labcorp, Myomo, Myriad, Nanomix, National Supercomputing Centre, Novacyt Group, Organovo, Pacific Biosciences of California, Pharmacyte, Phunware, Ping An Good Doctor, Predictive Laboratories, Resolution Medical, Roji Health Intelligence, Tarveda Therapeutics, Vitalhub, Wellgistics.
Physicians who perform a variety of device implant procedures face a difficult choice in determining whether a patient should be treated. A new article in the Journal of the American College of Cardiology (JACC) recommends that patients who ordinarily would be candidates for surgical aortic valve replacement (SAVR) might instead be referred for the transcatheter alternative.
HONG KONG – Whether bats are the source of COVID-19 is a debatable point; however, using sound to navigate like them could prove key for diagnostics and disease monitoring. Bat-Call Ltd. is using its auscultation technology in the battle against the pandemic. It said its patented artificial intelligence (AI) infra-sound analysis and deep learning classification technologies can support the early detection and monitoring of COVID-19 patients.
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