on THERACLION (EPA:ALTHE)
Theraclion submits Sonovein to the FDA after significant progress
On December 9, 2025, Theraclion announced the submission of its Sonovein® device to the FDA. A decision on this De Novo clearance application could be reached by mid-2026. Approval would allow Sonovein® to enter the US market, the largest for varicose vein treatment.
In 2025, Sonovein® received MDR certification in Europe and met the Chinese standard GB 9706.1-2020. Scientific publications have confirmed its effectiveness, including studies showing up to 97% effectiveness at 12 months.
Theraclion's presence at 16 congresses has increased its visibility among specialists. The value proposition of Sonovein®, combined with its effectiveness, was well received.
R. E.
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