Malakoff, France, November 5, 2026
Theraclion, a French medical technology company specializing in non-invasive therapeutic ultrasound solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization to its SONOVEIN® platform for the treatment of superficial venous reflux in the Great Saphenous Vein (GSV). The regulatory authorization was granted on November 4, 2026, marking a significant milestone in the development of non-invasive treatments for varicose veins in the United States. SONOVEIN® uses High-Intensity Focused Ultrasound (HIFU) technology to treat targeted veins from outside the body, eliminating the need for surgical incisions or intravascular catheters. The company stated that SONOVEIN® is the first and only HIFU platform to receive FDA marketing authorization for this specific treatment application through the De Novo regulatory pathway. The decision opens access to the U.S. varicose vein treatment market and creates new commercial opportunities for Theraclion as it moves from clinical validation toward broader market deployment.
FDA De Novo Authorization Introduces Non-Invasive Vein Treatment
The FDA’s De Novo pathway is designed for novel medical devices that present low-to-moderate risk and do not have an appropriate legally marketed predicate device. Through this regulatory route, the FDA establishes a new classification for the authorized medical technology. SONOVEIN® is intended for the coagulation of blood vessels in patients with superficial venous reflux affecting segments of the Great Saphenous Vein. Superficial venous reflux occurs when the valves inside veins fail to function properly, allowing blood to flow backward and accumulate in the lower extremities. This condition is a major underlying cause of varicose veins, which affect approximately one-third of adults. Conventional treatment approaches may involve endovenous catheter-based procedures, thermal ablation or surgery. In contrast, SONOVEIN® delivers focused ultrasound energy through the skin to the targeted vein without requiring an incision or an intravascular catheter. The technology provides a completely non-invasive treatment approach, potentially reducing procedural invasiveness and expanding treatment options for patients with superficial venous disease. The FDA authorization represents an important regulatory achievement for focused ultrasound applications in vascular care.
VEINRESET Clinical Study Demonstrates 96.8% Vein Closure
The FDA authorization was supported by results from the pivotal VEINRESET clinical study, which evaluated SONOVEIN® in 70 patients across four clinical centers in the United States and Europe. The study achieved its primary endpoint, demonstrating a 96.8% Great Saphenous Vein occlusion rate at 12 months following treatment. Vein occlusion is an important clinical measure because successful closure of the targeted vein is intended to address the abnormal blood flow associated with superficial venous reflux. The reported findings support the durability of vein closure following non-invasive HIFU treatment. According to Theraclion, no serious or unanticipated adverse events were reported during the study, and only one mild adverse event was observed. These findings provided clinical evidence supporting the FDA’s regulatory assessment of the device. The study’s results are particularly relevant because they demonstrate the potential of focused ultrasound technology to achieve targeted vascular treatment without the use of an intravascular catheter. However, continued clinical experience and post-market monitoring will be important in understanding the device’s performance across broader patient populations and routine clinical settings.
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U.S. Commercial Launch Opens New Growth Opportunities
Following FDA authorization, Theraclion is preparing to expand SONOVEIN® commercialization in the United States through its established U.S. subsidiary, Sonovein Inc. The company has completed several administrative, corporate and operational preparations to support market entry. Its initial commercial strategy will focus on establishing reference treatment centers, providing physician training, supporting clinical onboarding and ensuring technical and service assistance. An additional development supporting commercialization is the introduction of a dedicated Category III Current Procedural Terminology (CPT) code, which became active on October 1, 2026. The code provides a standardized mechanism for reporting and tracking non-invasive HIFU vein procedures and represents an initial step toward developing potential reimbursement and payment pathways. Theraclion expects the U.S. market launch to strengthen its relationships with physicians, treatment networks and potential commercial partners. The company also plans to complement its American expansion with ongoing commercial activities in Europe, market-access development in China and distributor-led growth in other international markets, including the Middle East. According to Theraclion Chief Executive Officer Martin Deterre, the authorization marks the beginning of a new commercial phase following years of technological development, clinical validation and regulatory preparation.
Overall, Theraclion’s FDA authorization for SONOVEIN® represents an important advancement in non-invasive medical technology for varicose vein treatment. Supported by encouraging 12-month clinical results, the HIFU platform introduces an alternative to conventional catheter-based procedures for eligible patients with superficial venous reflux. The upcoming U.S. commercial launch will be an important step in determining the technology’s clinical adoption and long-term market potential.
Source: Theraclion press release
