Home » EDAP Gets FDA’s OK to Market Ablatherm Integrated Imaging HIFU
EDAP Gets FDA’s OK to Market Ablatherm Integrated Imaging HIFU
Devices Submissions and Approvals
The FDA has granted urology devicemaker EDAP 510(k) clearance to market its Ablatherm ultrasound system for the ablation of prostate tissue.
Ablatherm-HIFU generally is recommended for patients with localized prostate cancer who are not candidates for surgery or who prefer an alternative option.
The French company says it will commercialize the device in the U.S. immediately. It is currently approved for commercial distribution in Europe and other countries, including Mexico and Canada.— Michael Cipriano