Herzliya-based health tech startup Respinova Ltd. has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Pulsehaler device for patients with respiratory problems, the company announced Tuesday.
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Driven by an internal turbine and multi-frequency vibration disc, Pulsehaler sends air pressure pulsations directly into the lung, making it easier to use for patients with airway restrictions.
Professor Raphael Breuer, former head of the Institute of Pulmonology at Hadassah University Medical Center, explained that "Despite the available pharma treatments, patients with COPD, Asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life."
Breuer said that Pulsehaler "brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly."
Respinova CEO Cliff Ansel said that FDA clearance was an "important milestone for the company."
