US CDC Teams Up With ACLA To Expand Monkeypox Testing
The US CDC and major laboratories across the country are working together to scale up testing capacity for monkeypox, especially now that it has been declared a public health emergency.
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The Centers for Disease Control and Prevention (CDC) is providing the non-variola orthopoxvirus test throughout its public health Laboratory Response Network. The diagnostic is currently the only FDA-cleared test to detect monkeypox.
The US FDA has updated guidance on computer-assisted detection devices that was first released in 2012. The document, which is intended to help developers win FDA approval of their products, was last updated in 2020.
The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.