EDAP Receives FDA 510(k) Clearance for Enhanced Focal One HIFU System
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
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Source: Newsfilter
- FDA Clearance: EDAP TMS SA announced that its Focal One High Intensity Focused Ultrasound (HIFU) system has received FDA 510(k) clearance, further solidifying the company's market leadership in robotic focal therapy for prostate cancer. This clearance introduces advanced ultrasound imaging and an optimized user interface, enhancing treatment planning efficiency.
- Technological Innovation: The next-generation ultrasound imaging engine provides real-time visualization and supports the development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation. This technological advancement not only improves treatment outcomes but may also expand the indications for Focal One.
- Market Outlook: CEO Ryan Rhodes stated that this FDA clearance represents an important technical milestone in Focal One's product roadmap, demonstrating the company's ongoing commitment to innovation. This will help the company further strengthen its leadership position in the global market, particularly in prostate cancer treatment.
- Company Background: EDAP TMS is a recognized leader in robotic energy-based therapies, focusing on the development and distribution of minimally invasive medical devices for various conditions. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP aims to meet the growing market demand.
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Analyst Views on EDAP
Wall Street analysts forecast EDAP stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for EDAP is 14.00 USD with a low forecast of 14.00 USD and a high forecast of 14.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 4.260
Low
14.00
Averages
14.00
High
14.00
Current: 4.260
Low
14.00
Averages
14.00
High
14.00
About EDAP
Edap Tms SA is a France-based company that develops, manufactures, promotes and distributes minimally invasive medical devices for urology based upon ultrasound technology. The Company's activity is organized in two divisions: HIFU (High Intensity Focused Ultrasound) and ESWL (Extracorporeal ShockWave Lithotripsy) that invests in research and development, partnering with INSERM French public laboratory and international medical research institutions. It specialises in HIFU technology, a non-invasive treatment of prostate conditions with a range of Robotic HIFU devices, Ablatherm Fusion and Focal One, ESWL and Stone Laser that offers a range of minimally invasive solutions covering the full scope of urinary tract stone indications. It also operates worldwide via a network of corporate offices, subsidiaries and distribution partners
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
EDAP Reports Record 2025 HIFU Revenue, Issues 2026 Guidance for 36%-38% Growth
- Record Quarterly Revenue: EDAP anticipates Q4 2025 global HIFU revenue between $12.9 million and $13.3 million, marking the highest quarterly revenue in its history, reflecting strong global demand and system sales growth.
- Annual Revenue Growth: The expected 2025 annual HIFU revenue ranges from $36.7 million to $37.2 million, representing the highest annual revenue in the company's history, indicating increasing market acceptance of the Focal One system.
- U.S. Procedure Growth: The number of Focal One HIFU procedures in the U.S. increased approximately 28% year-over-year in Q4, enhancing the company's competitive position in the U.S. market and demonstrating the effectiveness and trust in the new systems.
- 2026 Financial Guidance: The company expects core HIFU business revenue in 2026 to range from $50.0 million to $54.0 million, with combined non-core revenue projected between $22.0 million and $26.0 million, showcasing confidence in future growth and market potential.
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EDAP Reports Record 2025 HIFU Revenue, Issues 2026 Guidance for 36%-38% Growth
- Record Quarterly Revenue: EDAP anticipates Q4 2025 worldwide HIFU revenue between $12.9 million and $13.3 million, marking the highest quarterly revenue in its history, reflecting strong global demand and system sales growth.
- Annual Revenue Growth: The expected annual HIFU revenue for 2025 is projected to be between $36.7 million and $37.2 million, demonstrating the company's sustained growth and leadership in the medical device sector.
- Innovative System Deployments: The company achieved 15 Focal One system placements in Q4, a 69% year-over-year increase, which not only meets the demand from hospitals and urology centers but also strengthens EDAP's competitive position in prostate cancer treatment.
- 2026 Financial Guidance: EDAP projects its core HIFU business revenue for 2026 to be between $50 million and $54 million, with combined non-core revenue expected to range from $22 million to $26 million, showcasing the company's confidence and strategic planning for future growth.
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