New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
July 31, 2014
07:10 EDTEDAPEDAP TMS says FDA panel votes against Ablatherm-HIFU device
EDAP TMS announced last night that the FDA's Gastroenterology and Urology Devices Panel voted 3 yes, 5 no with 1 abstention on the question of safety, 9 no on the question of efficacy, and 8 no with 1 abstention for the risk/benefit ratio for the use of its Ablatherm-HIFU device for the treatment of low-risk, localized prostate cancer. Marc Oczachowski, EDAP's CEO, commented, "We are disappointed by the Committee's recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialogue during today's meeting. We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU's PMA."
News For EDAP From The Last 14 Days
Check below for free stories on EDAP the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
There are no results for EDAP

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use