Respinova’s Pulsehaler Device Wins FDA OK

Respinova’s Pulsehaler Device Wins FDA OK

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Respinova’s Pulsehaler Device Wins FDA OK

Respinova’s non-invasive Pulsehaler, a medical device meant to ease breathing in patients with airway restrictions, such as in cystic fibrosis (CF), has been cleared for marketing in the U.S. Pulsehaler was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) following the company’s submission of a premarket notification. This type of clearance is required when a device is marketed for the first time or when significant changes have been made to an already…

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