The Food & Drug Administration warned AngioDynamics Inc. (NSDQ:ANGO) for some allegedly over-zealous marketing of its NanoKnife system.
The FDA accused the Latham, N.Y.-based company of making statements on its website promoting the use of the device beyond its approved indications.
The NanoKnife has 510(k) clearance for surgical ablation of soft tissue, according to a press release, which didn’t specify which statements the FDA objected to.
AngioDynamics said it’s taking steps to remedy the issues raised in the letter, adding that it also wants to augment the currently approved labeling for the device, according to CEO Jan Keltjens.
"We remain committed to our strategy of working with the FDA toward expanded labeling for the NanoKnife system," Keltjens said in prepared remarks.
The FDA had not posted the the warning letter on its website as of about 1:45 Eastern today.