Pulsehaler™ Granted FDA 510(k) Clearance

6th April 2021

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).