AngioDynamics Halted; Receives FDA Warning Letter (ANGO)

AngioDynamics ANGO today announced the receipt of a warning letter from the U.S. Food and Drug Administration (FDA) regarding certain aspects of the Company's marketing program for its NanoKnife® System. The NanoKnife System continues to be commercially available in the United States under its 510(k) clearance for the surgical ablation of soft tissue 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. “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.”