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Medical Devices / Submissions and Approvals

FDA Grants Expedited Pathway Designation to AngioDynamics Cancer Treatment System

Jan. 26, 2018

New York-based devicemaker AngioDynamics obtained the FDA’s expedited access pathway designation for its NanoKnife ablation system for treatment of Stage III pancreatic cancer.

The system previously received 510(k) clearance for surgical ablation of soft tissue.

NanoKnife is designed to permanently open pores in targeted cell membranes via low energy direct current electrical pulses, resulting in cell death, and the patient’s body naturally removes the treated tissue “in a matter of weeks,” the company said.

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