FDA Issues Clinical Trial Guide For Prostate Tissue Ablation Devices

FDA issued draft guidance Tuesday (June 25) meant to help the medical device industry collect clinical data to demonstrate the safety and effectiveness of an emerging device category that uses ultrasound and other kinds of energy to destroy or remove harmful prostate tissue. Though FDA first granted de novo for such a device in 2015, the guidance comes as the agency works to learn more about radiofrequency ablation devices, particularly those that serve as a non-addictive form of pain management...