Medical device maker AngioDynamics Inc. said Tuesday it received a warning letter from regulators about marketing claims promoting its NanoKnife surgical system.
The Food and Drug Administration warned AngioDynamics that some of the company's statements promote use of NanoKnife in indications that go beyond its marketing approvals. That includes statements on the company's website, AngioDynamics said. In the U.S., NanoKnife is approved for the surgical ablation of soft tissue. The company said it will work with the FDA to resolve the issue.
In the six months ended Nov. 30, AngioDynamics reported $2.7 million in NanoKnife revenue.