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Emergency Guidance Clears Way For COVID-19 Blood Clot Detection Devices

The US FDA is waiving premarket notification requirements for coagulation systems to monitor COVID-19 patients who are at high risk for blood clotting.

3D rendering of the coronavirus and red blood cells.

The US Food and Drug Administration is waiving premarket notification requirements for coagulation systems that can help health care providers monitor COVID-19 patients at risk of blood clots.

On 14 January, the agency published an emergency guidance that allows the devices, which are used to measure viscoelastic...

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