Respinova Earns FDA Clearance for COPD Device
Respinova’s Pulsehaler, a device designed to treat chronic obstructive pulmonary disease (COPD), has been granted 510(k) clearance by the FDA.
According to the company, Pulsehaler is the first device that employs Dynamic Multi-frequency Pressure Pulse technology, using an internal turbine and multi-frequency vibration disc to send air pressure pulsations into the lung to effectively open small airways.
The gun-shaped device is held to the patient’s mouth, where it delivers pulses of air pressure to gently open collapsed airways. The pulses also help to smooth and spread the mucus lining layers on the airway walls to assist in airway clearance and reduce re-closing.