Theraclion Seeks US FDA Nod for Varicose Vein Treatment Platform

MT Newswires · 2d ago
01:16 AM EST, 12/10/2025 (MT Newswires) -- Theraclion (ALTHE.PA) submitted clinical data from a pivotal trial of its Sonovein robotic platform to the US Food and Drug Administration as part of the De Novo clearance process. The French medical device company expects to secure regulatory clearance by mid-2026, according to a Tuesday release. Sonovein is a non-invasive high-intensity focused ultrasound platform designed for varicose vein treatment.