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
Sign up for a free trial to see the rest of the stories you've been missing.
August 26, 2015
16:12 EDTEDAPEDAP TMS reports Q2 EPS EUR 0.02c vs. EUR (.23) in year ago quarter
Reports Q2 revenue $8.7M, one estimate $7.74M.
10:11 EDTEDAPHigh option volume stocks
Subscribe for More Information
August 25, 2015
08:34 EDTEDAPEDAP TMS submitted complete response to FDA deficiency list
Subscribe for More Information

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