MediValve said it won both CE Mark clearance in Europe and FDA 510(k) clearance in the U.S., for its acWire Guidewire.
Kibbutz Hama’apil, Israel-based MediValve started in 2010, as a portfolio company of The Trendlines Group. The company’s only product so far is the acWire.
The acWire Guidewire is a single-use device that acts as a positioning tool for peripheral vascular and heart catheterization procedures, for diagnostic and interventional devices. Landing both clearance in the U.S. and Europe is a big win for the small company, which means it can be marketed in both areas. No indication has been made on this front, according to a press release.
“We are thrilled to have reached the milestone of FDA pre-market clearance for our 510(k) application. In today’s challenging regulatory environment it is extremely exciting for a young company to achieve both CE and FDA pre-market clearances in the same month. We anticipate significant clinical interest for this innovative technology. This is the second in a series of regulatory applications as we continue our development of several additional acWire products,” CEO Assaf Klein said in prepared remarks.