The federal safety watchdog’s Expedited Access Pathway is designed to speed medical devices through the approval process to treat conditions with no available alternatives. The EAP program will transition to the Breakthrough Devices Program once the FDA finalizes its guidance. NanoKnife is a soft tissue ablation device.
“The Expedited Access Pathway and Breakthrough Devices Program is an important and meaningful initiative to prioritize review and approval for novel, innovative devices needed by patients for the treatment of life-threatening diseases and conditions. We are thrilled that the FDA has granted the EAP designation to NanoKnife for the treatment of Stage III pancreatic cancer and are excited to continue working with the FDA toward approval of NanoKnife as a treatment for the underserved patient population suffering from this deadly disease,” president & CEO Jim Clemmer said in prepared remarks.