Respinova Ltd. is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Pulsehaler™.
Pulsehaler™ is an innovative device that facilitates the opening of airways and clearance of secretions in patients with respiratory diseases. It 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.
Vincent Medical is a minority shareholder of Respinova Ltd. and the exclusive manufacturer and distributor of the PulsehalerTM in selective markets.
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).