Keeping you up to date on recent developments in diagnostics, including: Chest CT bests assays in diagnosing Covid-19; Sweat sensor keeps tabs on stress; Oligodendrocyte-neural connections not just about myelin; Sharper look yields new potential kinase target in ovarian cancer.
Rated the No. 1 most prepared country in the world to tackle an epidemic, the U.S. could see its preparedness put to the test as it responds to the growing COVID-19 outbreak. While the administration is pointing to that rating from a recent global survey to calm fears about the risk in the U.S., the coronavirus emergency is spotlighting cracks in the nation’s preparedness.
LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.
With the CDC saying Tuesday that it’s not if but when COVID-19 becomes more widespread in the U.S., now is not the time to cut the budgets of programs and agencies in the Department of Health and Human Services (HHS).
Nevro Corp.’s stock was up following encouraging results detailed during its fourth-quarter earnings call. Management predicted a positive 2020, highlighting the potential of the U.S. spinal cord stimulation (SCS) market. Keith Grossman, chair, CEO and president of the company, noted that the SCS market slowed last year as a result of stocking issues – a challenge that affected both it and its competitors.
“The FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruption to supplier shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said Tuesday, Feb. 25, during a Department of Health and Human Services (HHS) briefing on the COVID-19 outbreak.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Deka, Fresenius, Teva, United Therapeutics.
LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: 10X Genomics, Bio-Rad Laboratories, Sanofi SA.
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