Frey Medical (300049.SZ) participated in the company's core product SONOVEIN®, obtained approval from the US FDA De Novo

Zhitongcaijing · 2d ago

Zhitong Finance App News, Frey Medical (300049.SZ) issued an announcement. Recently, the company received a notice from the participating company Terraclion and FDA De Novo license approval. Its core product SONOVEIN® obtained a listing license granted by the US Food and Drug Administration (FDA) through De Novo (New Medical Device Classification Application) on November 4, 2026. This product is used for vascular coagulation treatment in patients with superficial venous reflux in the large saphenous vein (GSV) segment.

According to reports, the FDA's New Medical Device Classification Application (De Novo) route applies to low to medium risk novel devices. This approval makes SONOVEIN® the first and only non-invasive high-intensity focused ultrasound (HIFU) platform approved for the treatment of varicose veins in the US, providing a completely new treatment option performed entirely in vitro for varicose veins patients in the US.