Chinese FDA Approves Profound’s Sonalleve

Profound Medical received an approval from China’s FDA for its Sonalleve, a therapeutic platform used to perform ablation of diseased tissue.

Sonalleve offers women with uterine fibroids a non-invasive therapy that avoids performing hysterectomies in invasive surgery and hospitalization.

The device combines real-time magnetic resonance imaging and thermometry with thermal ultrasound to remove tissue without making incisions.