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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Emphasys panel review: FDA's Anesthesiology and Respiratory Therapy Devices panel will review Emphasys Medical's PMA application for its Zephyr endobronchial valve emphysema treatment at a Dec. 5 meeting, putting the Redwood City, Calif.-based firm one step closer to launching its first product on the U.S. market. Zephyr is CE-marked and sold on a limited basis in Europe and some parts of Asia. In July, CMS denied the firm's new technology add-on payment application because Zephyr had not yet gained FDA approval (1"The Gray Sheet" Aug. 11, 2008, p. 9)
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