Respinova Granted FDA 510(k) Clearance for Pulsehaler™
USA - English
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HERZLIYA, Israel, April 6, 2021 /PRNewswire/ Respinova Ltd. is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Pulsehaler™. Pulsehaler™ is an innovative device that facilitates the opening of airways and clearance of secretions in patients with respiratory diseases. Despite the available pharma treatments, patients with COPD, Asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life, commented Professor Raphael Breuer, MD, former Head of the Institute of Pulmonology at Hadassah University Medical Center. Pulsehaler™ brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly , he added.