The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
Governments across the globe are struggling to keep pace with the SARS-CoV-2 virus’s impact on public health, but the new variants are presenting their own challenges. The next task facing governments across the globe is to sequence the latest mutated variants of the virus and keep track of any further mutations, all while validating new and revamped existing tests, a task that is likely to prove difficult to meet for at least the next few months.
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.
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