There has been a lot of chaos at the US Food and Drug Administration since the Trump administration took office in January. Some of that is due to the normal hiccups that occur during regime transitions, but some — such as the firing and rehiring of device center staffers — is not.
But medtech companies developing AI products can’t wait for the FDA to gain its footing on this front, which means in many respects they are flying blind, as Robert Cohen,...
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