Edap Seeks New Marketing Clearance for Ultrasound Device
Edap submitted a new 510(k) application for its next-generation ultrasound Focal One device designed for use in prostate cancer surgery. The company withdrew a previous application in July.
The device is designed to allow urologists to import pre-treatment diagnostic information, including MRI images and 3D biopsy maps, and merge them with live ultrasound images during prostate tissue ablation procedures.
The new application includes a new set of clinical data.