The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Binx Health, Gold Standard Diagnostics, Nines.
Thermo Fisher Scientific Inc. has launched a surveillance system that can detect SARS-CoV-2 in ambient air in indoor spaces, providing a potential complement to individual testing and other COVID-19 safety protocols. The system, called the Aerosolsense Sampler, works by capturing a sample of the ambient air on a cartridge using Thermo Fisher’s collection substrate.
LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helius Medical Technologies, Medtronic, Qiagen, STS Lab.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Batm, Bracco Diagnostics, Cardionavix, Casamba, Coloplast, Escher Biomedical Diagnostics, Health Logic Interactive, Hitachi, Hoya, Lumendi, Meso Scale Diagnostics, Net Health Systems, Orbita, Philips, Vizient.
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
TORONTO – A distinguished Canadian health care policy expert said a report from Canada’s COVID-19 Testing and Screening Expert Advisory Panel recommending testing and screening for school-age children and teachers comes “late in the game” now that the focus has shifted to vaccinating the Canadian population.
