EDAP seeks clearance for ultrasound device

French therapeutic ultrasound developer EDAP TMS has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its Focal One high-intensity focused ultrasound (HIFU) device.

The submission follows the November 2015 FDA clearance of the company's Ablatherm robotic HIFU device for the ablation of prostate tissue.

Page 1 of 1252
Next Page