The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reissues policy for coagulation systems; FDA announces recall of Penumbra’s Jet 7; Stericycle to buy buses as part of settlement; Athena agrees to $18M fine; WHO refreshes essential diagnostics list; TGA pulls two pandemic-driven exemptions.
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
The Xpert MTB/XDR test developed by the Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. quickly indicates whether a patient has a dangerous – and rapidly increasing – strain of multidrug resistant tuberculosis (TB). The new test enables clinicians to return results in 90 minutes and see immediately whether the pathogen would respond to standard first- or second-line therapies.
LONDON – Two months after the launch, the World Health Organization (WHO) has laid out the spending plans for its push to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics.
LONDON – Two months after the launch, the World Health Organization (WHO) has laid out the spending plans for its push to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics.
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits.
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits.
LONDON – After all the controversy and a huge dose of hype, there is no clinical benefit from the use of hydroxychloroquine in patients admitted to the hospital with COVID-19, according to headline data from a large randomized trial of potential drugs for the infection currently running in the U.K.
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