Theraclion’s Sonovein Receives the US FDA’s De Novo Authorization for Non-Invasive Treatment of GSV Reflux

Shots: The US FDA has granted De Novo marketing authorization (Nov 4, 2026) to Theraclion’s Sonovein for coagulation of blood vessels in pts with superficial venous reflux in Great Saphenous Vein (GSV) segments, establishing a new device classification Authorization was supported by the Pivotal (VEINRESET) study (n=70; 4 US & EU centers; NCT05926830), which met its 1EP with a 96.8% GSV occlusion rate at 12mos., with no serious or unanticipated AEs & 1 mild AE Sonovein delivers non-invasive HIFU through the skin without incision or intravascular catheter; US subsidiary Sonovein Inc. is prepared for launch, with a Category III CPT code active since Oct 1, 2026 Ref: Theraclion  |   Image: Theraclion  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Theraclion’s Sonovein Receives the US FDA’s De Novo Authorization for Non-Invasive Treatment of GSV Reflux appeared first on PharmaShots.