EDAP TMS SA : EDAP Announces FDA Clearance for Focal One®
EDAP TMS S.A. - American Depositary Shares, each representing One Ordinary Share (EDAP)
Last edap tms s.a. - american depositary shares, each representing one ordinary share earnings: 3/30 04:35 pm
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Source: GlobeNewswire
AUSTIN, TX, LYON, FRANCE -- JUNE 7, 2018 -- EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Focal One device for the ablation of prostate tissue. The Focal One high intensity focused ultrasound (HIFU) device is the first medical apparatus designed specifically for focal treatment of the prostate. Focal One fuses MR and 3D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3D images of the prostate on a large monitor and direct high intensity ultrasound waves to ablate the targeted area. With Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and minimizes side effects of incontinence and impotence for patients. Using Focal One, surgeons can customize
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News
- EDAP Announces Final Results from HIFI Study Comparing Outcomes of Focal One® HIFU Versus Radical Prostatectomy to be Presented During Plenary Session at the Upcoming 119th American Urological Association (AUA) Annual Meeting [Yahoo! Finance]Yahoo! Finance
- EDAP Announces Final Results from HIFI Study Comparing Outcomes of Focal One® HIFU Versus Radical Prostatectomy to be Presented During Plenary Session at the Upcoming 119th American Urological Association (AUA) Annual MeetingGlobeNewswire
- Edap Tms S.A. (NASDAQ: EDAP) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- Edap Tms S.A. (NASDAQ: EDAP) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Edap Tms S.A. (NASDAQ: EDAP) had its price target raised by analysts at HC Wainwright from $16.00 to $19.00. They now have a "buy" rating on the stock.MarketBeat
EDAP
Earnings
- 3/27/24 - Miss
EDAP
Sec Filings
- 4/17/24 - Form EFFECT
- 4/5/24 - Form F-3
- 3/28/24 - Form 20-F
- EDAP's page on the SEC website