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EDAP TMS Secures FDA Clearance for Enhanced Focal One HIFU System

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EDAP TMS Secures FDA Clearance for Enhanced Focal One HIFU System

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EDAP TMS ( (EDAP) ) has shared an update.

On November 20, 2025, EDAP TMS announced that it received FDA 510(k) clearance for enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system. This clearance introduces advanced ultrasound imaging and workflow improvements, reinforcing EDAP’s leadership in robotic focal therapy for prostate cancer. The updates include a new imaging engine that supports real-time visualization and the potential for AI-driven algorithms, marking a significant technical milestone for the company. This development is expected to strengthen EDAP’s market position and commitment to innovation in the field.

The most recent analyst rating on (EDAP) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on EDAP TMS stock, see the EDAP Stock Forecast page.

Spark’s Take on EDAP Stock

According to Spark, TipRanks’ AI Analyst, EDAP is a Neutral.

EDAP TMS’s overall stock score is primarily impacted by its financial performance challenges, particularly in profitability and cash flow management. While the earnings call provided some positive insights into revenue growth and strategic advancements, the technical analysis and valuation metrics indicate bearish sentiment and ongoing financial struggles.

To see Spark’s full report on EDAP stock, click here.

More about EDAP TMS

EDAP TMS is a recognized leader in robotic energy-based therapies, developing, manufacturing, and distributing minimally invasive medical devices worldwide. The company focuses on using ultrasound technology for various conditions, with a particular emphasis on prostate focal therapy. Their flagship product, Focal One, is a leading prostate focal therapy device controlled by urologists, with potential applications beyond prostate cancer.

Average Trading Volume: 92,456

Technical Sentiment Signal: Sell

Current Market Cap: $83.38M

See more insights into EDAP stock on TipRanks’ Stock Analysis page.

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