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'Countermeasure' Devices Needed For Infants, FDA Says – Just In Case

The U.S. needs devices specifically designed for infants for its Strategic National Stockpile, FDA officials said at a Feb. 15-16 meeting.

The nation needs several pediatric devices, including N95 respirators and ventilators for infant use – to counter potential biological, chemical or nuclear terrorist attacks or disease pandemics, FDA device center officials said.

FDA is encouraging manufacturers to develop these and other items, and submit them for clearance or approval even as investigational...

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The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

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EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

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