We are pleased to announce that on January 8, 2014, our tremoFlo C-100 Airwave Oscillometry System received its CE Mark as a class II medical device. This makes the tremoFlo C-100 the first and only approved handheld Oscillometry system for effortless lung function testing in Europe.
“The CE Mark is an important milestone on our regulatory and go-to-market roadmap,” says Thomas F. Schuessler, President and CEO of THORASYS Thoracic Medical Systems Inc. “I would like to thank all members of our excellent team for their dedication and hard work that has allowed us to reach this important milestone on schedule.”
Europe is the first jurisdiction where the tremoFlo C-100 is authorized as a medical device to diagnose and monitor lung disease. Applications for regulatory approval are currently in progress in a variety of other jurisdictions, including Canada and the United States, and updates will be provided regularly on this blog.
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