1 comments

  • ano-ther 18 hours ago ago

    Here is the FDA's warning letter: https://www.fda.gov/inspections-compliance-enforcement-and-c...

    Responding to an FDA warning letter (sent after previous interaction) with a marketing blog post takes some chuzpe. They even include "We stand by its accuracy, which the FDA has not questioned," as if FDA had assessed that for a device they haven't submitted for review.