AngioDynamics Warned by FDA on NanoKnife Promotion
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AngioDynamics Inc. said it received a letter from U.S. regulators alleging the company promoted its NanoKnife surgical device for unapproved uses.
The Food and Drug Administration notified Latham, New York-based AngioDynamics in a warning letter that some of the company’s statements, including those on its website, “promote the use of the NanoKnife System beyond its currently cleared indications,” AngioDynamics said today in a statement.