AngioDynamics has received the US Food and Drug Administration (FDA) warning letter regarding certain aspects of the marketing program for its NanoKnife System.
The NanoKnife System is indicated for surgical ablation of soft tissue.
The system continues to be commercially available in the US under its 510(k) clearance and in certain international markets under CE Mark or other relevant approvals.
The FDA letter states that certain statements made by AngioDynamics, including those on its Web site, promote the use of the NanoKnife System beyond its currently cleared indications.
AngioDynamics is taking actions to address the matters raised by the FDA and will work closely with the agency to resolve any outstanding issues.
AngioDynamics president and CEO Jan Keltjens said their goal is to always comply with all regulations regarding their products.
"We have already begun to respond to the matters raised by the FDA and are committed to addressing them promptly. We remain committed to our strategy of working with the FDA toward expanded labeling for the NanoKnife System," Keltjens said.