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EDAP TMS SA (Nasdaq: EDAP) is described in its filings and press releases as a global leader in robotic energy-based therapies, focused on High-Intensity Focused Ultrasound (HIFU) and related ultrasound-based medical devices. The EDAP news feed on Stock Titan aggregates company announcements, financial updates and regulatory disclosures so readers can follow developments around its Focal One Robotic HIFU platform and broader therapeutic ultrasound portfolio.
Recent news from EDAP highlights HIFU revenue growth, system placements and procedure volumes, as well as guidance on expected revenue trends in its core HIFU business and non-core ESWL and Distribution segments. The company regularly reports unaudited quarterly financial results via Form 6-K, including details on sales of medical equipment, recurring revenue programs, and spare parts and services, along with commentary on gross margins and operating performance.
Investors and healthcare observers can also use the news stream to track regulatory milestones and clinical adoption. EDAP has announced FDA 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One HIFU system, as well as reimbursement in France for Focal One Robotic HIFU procedures in prostate cancer under the national universal health system. News items further cover recognition such as an Industry Award for Innovations in Endourological Instrumentation for the Focal One platform.
Other news categories include financing and capital structure updates, such as a multi-tranche credit facility with the European Investment Bank intended to support expansion of the Focal One platform, and information about EDAP’s transition from foreign private issuer to U.S. domestic filer status. Coverage of conference presentations and investor meetings provides additional context on how management presents the company’s strategy in urology, prostate cancer and benign disease markets.
By reviewing the EDAP news page, readers can follow company-reported trends in HIFU adoption, reimbursement developments, clinical evidence references and financial guidance, all drawn from EDAP’s own press releases and SEC-reported materials.
EDAP (Nasdaq: EDAP) reported first quarter 2026 results with record HIFU revenue of $11.6 million, up 78% year over year. The company sold 11 Focal One systems (+83% YoY) and U.S. procedures rose 53% YoY. Total revenue was $17.8 million.
Gross margin improved to 45.7%, operating loss was $7.4 million, and net loss was $9.1 million or ($0.24) per share. 2026 HIFU revenue guidance remains $50.0M–$54.0M.
EDAP TMS (Nasdaq: EDAP) published the HIFI-2 prospective multicenter study on salvage Focal One Robotic HIFU for prostate cancer recurrence after radiotherapy.
The dataset includes 531 patients across >30 centers, reporting 71% androgen deprivation therapy–free survival (ADT-FS) at 30 months, up to 84% ADT-FS in favorable subgroups, low severe complication rates, and preserved quality of life at 12 months.
EDAP (Nasdaq: EDAP) will release first quarter 2026 financial results before market open on May 7, 2026. A conference call and webcast with CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch is scheduled for 8:30 a.m. EDT the same day.
Investors can join via domestic and international dial-in numbers using passcode EDAP, or access the live webcast through the provided registration link.
EDAP (Nasdaq: EDAP) reported record fourth-quarter and full-year 2025 HIFU revenue, driven by higher Focal One system sales and U.S. procedure growth.
Full-year HIFU revenue rose 39% YoY; the company reiterated 2026 revenue guidance of $72.0M–$80.0M, with core HIFU revenue expected to grow 34%–45% YoY.
EDAP (Nasdaq: EDAP) will present at the Oppenheimer 36th Annual Healthcare MedTech & Services Conference on Wednesday, March 18, 2026. CEO Ryan Rhodes will deliver a virtual presentation and, with CFO Ken Mobeck, host one-on-one investor meetings from 12:00–12:30 PM ET. A live and archived webcast is available.
EDAP (Nasdaq: EDAP) will release fourth quarter and full year 2025 financial results before market open on Wednesday, March 25, 2026.
The company will host a conference call and webcast on March 25 at 8:30 a.m. EDT featuring CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch. Dial-in and webcast registration details are provided.
EDAP (Nasdaq: EDAP) announced the appointment of David Horn to its Board of Directors, effective February 11, 2026, and the departure of Glen French, effective February 10, 2026.
Mr. Horn will join the Audit Committee and Nominations Committee, bringing capital markets and medical device experience from roles at Seer, Morgan Stanley, RITA Medical Systems, and Chemdex.
EDAP (Nasdaq: EDAP) reported preliminary unaudited results showing record fourth-quarter and full-year 2025 HIFU revenue driven by increased Focal One system sales and growing U.S. procedure volume. Q4 2025 HIFU revenue is expected to be $12.9M–$13.3M and full-year 2025 HIFU revenue $36.7M–$37.2M, both company records. Q4 included a record 15 Focal One system placements and ~28% YoY growth in U.S. Focal One procedures. EDAP issued 2026 guidance of $50.0M–$54.0M HIFU revenue (36%–38% YoY growth) and combined non-core revenue of $22.0M–$26.0M. Results are preliminary and unaudited; final 2025 results expected in March 2026.
EDAP (Nasdaq: EDAP) announced that the U.S. Food and Drug Administration granted 510(k) clearance on November 20, 2025 for ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system.
The clearance covers an upgraded ultrasound imaging engine, streamlined treatment planning and an optimized user interface for the Focal One i, enabling real-time visualization and supporting potential future AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation.
Company commentary cites this clearance as a technical milestone that reinforces Focal One’s market leadership in robotic focal therapy for prostate cancer.
EDAP (Nasdaq: EDAP) will present at the Piper Sandler 37th Annual Healthcare Conference in New York City on Tuesday, December 2, 2025. Chief Executive Officer Ryan Rhodes will deliver a fireside discussion at 10:30–10:55 am ET, and CEO Rhodes together with Chief Financial Officer Ken Mobeck will host one-on-one investor meetings the same day.
Location: The Lotte New York Palace. A live webcast and archived replay will be available via the conference link https://event.webcasts.com/starthere.jsp?ei=1743759&tp_key=aa01607b94 and in the Investors section of the company website.