News Headlines Article

FDA rule clears medical devices without human testing
Orange County Register

Laurie Kelly blinked awake from surgery at Hoag Hospital in Newport Beach, grateful for the cutting-edge technology that gave her the chance to beat breast cancer in a single day. That June 2010 morning, Hoag doctors removed a tumor from her left breast. Then they positioned their brand-new Xoft Axxent device to deliver a high dose – 20 gray – of electron radiation to her surrounding flesh, eliminating the need for six weeks of treatment. Kelly’s healthy tissue was protected by the Axxent FlexiShield Mini, a malleable metal pad made of silicone-wrapped tungsten.