Interventional technology developer AngioDynamics has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding marketing of its NanoKnife surgical ablation system.
In the letter, the FDA stated that certain statements made by AngioDynamics, including those on its Web site, promote the use of the NanoKnife beyond its currently cleared indications for the surgical ablation of soft tissue, according to the Latham, NY-based firm.
AngioDynamics said it is taking actions to address the matters raised by the FDA and will work closely with the agency to resolve any outstanding issues.
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