FDA: Edap's Ablatherm prostate cancer device 'not approvable'

Edap TMS says the FDA sent it a 'not approvable' letter for its Ablatherm prostate cancer treatment, but the French company has until April 2015 to update its pre-market approval application.

EDAP TMS SA, Food & Drug Administration (FDA)

News Well, Pre-Market Approval (PMA), Prostate, Regulatory/Compliance, Urology

read more

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1xcMFFq