EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU
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
Check Earnings Report
US:NASDAQ Investor Relations:
investor.edap-tms.com/investor-relations
Company Research
Source: GlobeNewswire
EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening the company’s market leadership in robotic focal therapy for prostate cancer. The 510(k) clearance introduces advanced ultrasound imaging, streamlined treatment planning, and an optimized user-interface to the Focal One i launched earlier this year. The next generation ultrasound imaging engine provides real-time visualization and supports the potential development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation. “We are proud to receive this new FDA clearance, which further enhances the capab
Show less
Read more
Impact Snapshot
Event Time:
EDAP
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
EDAP alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
EDAP alerts
High impacting EDAP TMS S.A. - American Depositary Shares, each representing One Ordinary Share news events
Weekly update
A roundup of the hottest topics
EDAP
News
- Edap Tms (NASDAQ:EDAP) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- EDAP to Present at Piper Sandler 37th Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- EDAP to Present at Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
- Edap Tms (NASDAQ:EDAP) had its "hold" rating reaffirmed by analysts at Jefferies Financial Group Inc..MarketBeat
- Edap TMS SA (EDAP) Q3 2025 Earnings Call Highlights: Record Revenue and Strategic Growth in HIFU [Yahoo! Finance]Yahoo! Finance
EDAP
Earnings
- 11/6/25 - Beat
EDAP
Sec Filings
- 11/20/25 - Form 6-K
- 11/18/25 - Form 6-K
- 11/6/25 - Form 6-K
- EDAP's page on the SEC website