Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biotia, Diazyme, Helio Health, Letsgetchecked, Mesi, Natera, Tempus, Tivic Health, Twist Bioscience.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainscope, Optellum, Ortho Clinical Diagnostics, Shape Memory Medical.
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.
CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events.
A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia.
The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.
