EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis
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
Focal One HIFU has potential to address large market impacting thousands of women each year LYON, France, March 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue. “Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives. By expanding our proprietary roboti
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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