Respinova Granted FDA 510(k) Clearance for Pulsehaler™
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.
"This FDA clearance for Pulsehaler™ is an important milestone for the company," said Cliff Ansel, CEO of Respinova Ltd. "We are excited to bring this innovative technology to respiratory patients".
Pulsehaler™ is the first device to use patented Dynamic Multi-frequency Pressure Pulse™ technology. 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.
About Respinova Ltd.:
Respinova is a privately held medical technology company based in Herzliya, Israel. Our team has decades of experience in developing and commercializing innovative medical devices in diverse therapeutic areas. Respinova is a two-time winner of the prestigious European Horizon program (Horizon 2020 SME and Horizon EIC).
SOURCE Respinova Ltd.