Tag: Breakthrough Device Designation

Breakthrough Device designation granted for Efemoral scaffold system designed to treat...

Efemoral Medical has announced the granting of Food and Drug Administration (FDA) Breakthrough Device status for its novel Efemoral vascular scaffold system (EVSS) designed...

Cook Medical receives FDA breakthrough designation for new drug-eluting stent

Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee...

FDA grants Nexus aortic arch stent graft system breakthrough designation

Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough...