AngioDynamics granted FDA approval to initiate NanoKnife DIRECT study

AngioDynamics announced that the United States FDA approved the company’s investigational device exemption application for its NanoKnife Irreversible Electroporation “Direct IRE Cancer Treatment” clinical study. The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. In January 2018, the FDA granted the company’s NanoKnife System a Breakthrough Device Designation under the 21st Century Cures Act.

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