Tag: US

Impede embolization plug gets US FDA clearance

Shape Memory Medical announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Impede embolization plug. The device...

BIOFLEX-1 pivotal trial results demonstrate safety and efficacy of Pulsar-18 stent...

Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked...

US study suggests fibroid embolization “vastly underutilised” compared with hysterectomy

A large US nationwide study shows that the uterine fibroid embolization is vastly underutilised, compared to hysterectomy—especially in rural and smaller hospitals. In fact, there...

Medtronic gets FDA clearance of new lower profile HawkOne 6F directional...

Medtronic has received US FDA 510(k) clearance for the HawkOne directional atherectomy system in a new size for treating patients with peripheral artery disease....