Category: EDAP TMS SA
The FDA's expert advisory panel votes that French device maker EDAP failed to demonstrate that it's 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.
EDAP TMS lands a July date with FDA advisors to review therapeutic ultrasound in treatment of localized prostate cancer.
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.