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AUSTIN, Texas - EDAP TMS SA (NASDAQ:EDAP) announced Thursday that the U.S. Food and Drug Administration has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to its Focal One High Intensity Focused Ultrasound (HIFU) system. The small-cap medical device company, currently valued at $83.38 million with shares trading at $2.23, has seen its stock climb 17.37% over the past six months, according to InvestingPro data.
The clearance covers advanced ultrasound imaging, streamlined treatment planning, and an optimized user interface for the Focal One i system that was launched earlier this year. According to the company's press release, the next generation ultrasound imaging engine provides real-time visualization and supports potential development of AI-driven algorithms to assist surgeons with tissue ablation visualization and treatment evaluation.
"We are proud to receive this new FDA clearance, which further enhances the capabilities of the new Focal One i and represents another important technical milestone in Focal One's product roadmap," said Ryan Rhodes, Chief Executive Officer of EDAP TMS. Despite this regulatory achievement, InvestingPro analysis indicates the company is not expected to be profitable this year, with analysts forecasting an EPS of -$0.69 for 2025. The company generated $74.9 million in revenue over the last twelve months, with a 0.61% year-over-year growth rate.
EDAP TMS describes itself as a developer and manufacturer of minimally invasive medical devices using ultrasound technology. The company introduced Focal One in Europe and the U.S. as a prostate focal therapy controlled by urologists.
The FDA clearance represents a regulatory milestone for the company's robotic HIFU technology, which is designed for prostate cancer treatment. The information in this article is based on a company press release statement.
In other recent news, EDAP TMS S.A. reported its third-quarter earnings for 2025, showing a net loss of €0.13 per share, which was better than the analyst forecast of a -$0.2108 EPS. The company achieved revenue of €13.9 million, reflecting a 6% increase compared to the previous year. Additionally, EDAP TMS recorded third-quarter sales of $16 million, surpassing consensus estimates of $15 million. The company also successfully placed eight Focal One units during the quarter, exceeding Jefferies' expectations of more than four units. In light of these developments, Jefferies raised its price target for EDAP TMS from $1.80 to $2.00, while maintaining a Hold rating on the stock. These recent developments highlight EDAP TMS's improved financial performance and strategic growth initiatives.
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