Signed by President Obama in December 2016, the 21st Century Cures Act added a new section (515C) to the Food Drug and Cosmetics Act (FDCA) to codify a process for priority review of Breakthrough Devices offering more effective treatment of “life-threatening or irreversibly debilitating human disease or conditions” under FDA’s Expedited Access for Pre Market Approval (EAP) guidance. Read more . . .
NeoTherma Oncology, (NTO) a privately held medical device company developing novel non-invasive treatments for solid tumors, today announces that the United States Food and Drug Administration (FDA) has granted the company’s petition to admit its Vectron TTx treatment for Pancreatic Cancer as Breakthrough Device under FDA’s Expedited Access Pathway (EAP).