France-based EDAP TMS SA will get its day with the FDA next month, when the agency’s expert advisors will review EDAP’s Ablatherm-HIFU therapeutic ultrasound technology for treatment of prostate cancer.
EDAP has a clear path forward to approval and will meet July 30 with the FDA’s Gastroenterology & Urology Devices Panel to present clinical data on Ablatherm-HIFU, the company said. The panel date came more than a year after the company filed its PMA application in April 2013.
"Confirmation of this important milestone is great news for the company and its PMA application," CEO Marc Oczachowski said in prepared remarks. "We are very excited to now have a much clearer path toward FDA approval and the entire team at EDAP is diligently preparing for this major event in the PMA application process."
The minimally invasive Ablatherm platform uses high-intensity focused ultrasound to target tumors while leaving surrounding tissue intact. The device is already approved in the European Union, EDAP noted.