FDA says NeoMedix is selling glaucoma device without approval

FDA officials issue a warning letter citing NeoMedix for selling its Trabectome High Frequency Generator for indications not approved for the U.S. market.

FDA officials chided medical device maker NeoMedix Corp. for violations of U.S. law, saying that the company is selling its Trabectome device without proper agency approval.

Food & Drug Administration (FDA), NeoMedix

News Well, Ablation, Food & Drug Administration (FDA), Regulatory/Compliance, Warning Letter

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