Agree, the gender difference was ridiculous from the start, call that half the FDAs fault for stalling on behalf of their pill-pushing patrons, and half on BIEL for not seeing the gender differences before submitting.
Yes, the PR is frustrating because we go from countdown mode back to zero, but their 510k never should have been gender specific to begin with.
How many macho athletes are going to use a device cleared, or initially cleared, only for women. It seems silly, but the FDA lead us down a rabbit hole and I’m glad we are getting out, better late than never.
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