AngioDynamics has acknowledged receiving a warning letter from the FDA regarding certain aspects of the company’s marketing program for its NanoKnife system.
The FDA letter stated that certain statements made by AngioDynamics, including those on its website, promote the use of the NanoKnife system beyond its currently cleared indications.
The Albany, N.Y.-based 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. The NanoKnife system continues to be commercially available in the U.S. under its 510(k) clearance for the surgical ablation of soft tissue during oncology procedures.
“Our goal is to always comply with all regulations regarding our products,” said Jan Keltjens, AngioDynamics president and CEO. “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.”