Category: EDAP TMS SA
Here's a look at some of the top regulatory stories for medical device companies this week: Medical device makers face new obstacles to European approval; FDA panel narrowly OKs Cohera Medical's TissuGlu; FDA cuts fiscal 2015 user fees; Catching up with the FDA's 2014 guidance; FDA panel votes against EDAP's ultrasound prostate cancer ablation
An FDA advisory panel votes that French device maker Edap failed to demonstrate that its novel Ablatherm prostate cancer treatment is safe and effective.
The FDA's expert advisory panel votes that French device maker EDAP failed to demonstrate that its novel Ablatherm prostate cancer treatment is safe and effective.
The FDA's Gastroenterology & Urology Devices panel today voted against recommending approval of EDAP's (NSDQ:EDAP) Ablatherm system for thermal ablation of the prostate gland to treat low-risk, localized prostate cancer.
LYON, France -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP's manufacturing site with no findings nor issuance of Form 483 observations.
FDA inspectors find no issues at EDAP's manufacturing facility, putting the company one step closer to winning premarket approval for its ultrasound-based prostate cancer treatment.
Here's a look at some of the top funding stories for medical device companies this week: Mass. General gets $30M DoD grant to build brain implant for mental illness; Consano raises $3.9M to connect researchers with funders; M&A: Spectranetics prepares $200M offering to fund $230M AngioScore bid; EDAP outlines road to FDA approval for prostate cancer ultrasound therapy; Samsung dives into digital health with open platforms, $50M fund.
French device maker EDAP TMS SA has a big month ahead as it pursues FDA approval for its Ablatherm-HIFU therapeutic ultrasound technology, preparing for regulatory inspections and launching a $9.3 million funding round.