Theraclion's Ultrasound Platform Sonovein Wins De Novo Marketing Approval in US

01:30 AM EST, 11/06/2026 (MT Newswires) -- Theraclion (ALTHE.PA) secured the US Food and Drug Administration's De Novo marketing authorization for Sonovein, its therapeutic ultrasound platform. The non-invasive treatment method is indicated for the coagulation of blood vessels in patients with superficial vein reflux in the great saphenous vein segments, according to a Friday release. The approval is backed by the results of the Veinreset study, which met its primary endpoint with a 96.8% great saphenous vein occlusion rate at 12 months. The French medical technology company will initially roll out Sonovein through physician training, clinical onboarding and technical and service support.