AACHEN, Germany--(BUSINESS WIRE)--Hemovent GmbH announced today that it has received CE marking for its MOBYBOX™ Runner™ Controller, allowing the company to market its innovative product throughout the European Union.
“With the Runner EU regulatory approval we have created an entirely new solution for the extreme challenges of ECLS deployment in situations with unpredictable and severely restricted emergency environments,” said Oliver Marseille, PhD, chief technology officer of Hemovent, and a co-founder of CircuLite® (Heartware® International) prior to co-founding Hemovent.
“The Runner is designed to slingshot clinicians into a new era of mobility and ease of use: Rather than bringing their patient to ECLS, the MOBYBOX with Runner Controller brings ECLS to their patients,” said Christof Lenz, a co-founder and CEO of Hemovent. “It is by factors smaller than any device on the market, yet can manage both blood and gas flow at the same time, with just two control knobs.”
The company has been granted CE mark for the MOBYBOX System with the Master Controller in 2019 and is currently in preparing a post market clinical follow-up trial.
Hemovent is an emerging medical device company with a proprietary platform technology for heart and lung support.
CAUTION: The Hemovent MOBYBOX System is not approved for distribution or sale outside of the European Union.