Keeping you up to date on recent developments in diagnostics, including: A deep learning tool to predict cardiovascular risk; Smartphone-based COVID-19 test; PCOS passed on in the epigenes.
The U.S. FDA is still struggling to keep up with the volume of diagnostic emergency use authorizations (EUAs), but it is not for want of effort. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said on the Feb. 3 testing town hall that the agency is processing nine such applications per day, a big jump over the rate of one per day in the early weeks of the COVID-19 pandemic.
HONG KONG – Seegene Inc. has developed a COVID-19 test kit that is able to both detect and identify multiple mutant variations of the virus. “Getting test results from the Allplex SARS-CoV-2 Variants Ⅰ Assay takes two hours, which is normally how long getting results from a PCR test takes,” a Seegene spokesperson told BioWorld.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force gives CAS screening another thumbs down; USPTO expands program with Japan’s, South Korea’s patent offices; Boston Sci recalls electrode for ICD due to risk of fracture; CDSCO posts lists of approved tests.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ardent Health Services, Ams, Axim Biotech, Bendcare, Botanisol Analytics, Casenet, Centene, Color, Colossal Contracting, Congenica, Decipher, Epredia, Extra Horizon, Fujifilm, Gabriel Precision Oncology, Gpm, Histosonics, Inspiremd, McGinley Orthopedics, Medline, Meridian Bioscience, Mobile Heartbeat, Netsmart, New England Biolabs, Ocean Insight, Quantumdx, Veeva, Veracyte, Vizient, Zyter.
While the Biden administration’s America Rescue Plan began its journey through Congress Feb. 3 as the next U.S. effort to address the COVID-19 pandemic, lawmakers came together to identify steps to improve vaccine distribution and curb ongoing supply shortages.
Visby Medical Inc. secured $12.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a next generation device to detect influenza and COVID-19 in a single point-of-care rapid PCR test and, subsequently, as an over-the-counter test for consumer use. The contract may be extended up to a total of $48.7 million over a period of 38 months based on meeting certain milestones in the base period, according to Visby Founder and CEO Adam de la Zerda.
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
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