Activaero's Watchhaler receives FDA 510(K) clearance
The US FDA has issued 510(K) clearance for Activaero's Watchhaler spacer, a revolutionary inhalation concept for children.
The US FDA has issued 510(K) clearance for Activaero's Watchhaler spacer, a revolutionary inhalation concept for children.
The 510(k) clearance allows German-based Activaero, a leader in controlled breathing technologies for inhaled therapeutic agents, to market the Watchhaler device in the US. It was previously launched in Europe in April 2007.
Watchhaler is a reservoir system, or "spacer", controlling the inhalation flow rate and volume to target the aerosol specifically to the lung region. This system is particularly tailored to the needs of child patients using asthma medication. The child friendly Watchhaler spacer is designed for use with standard metered dose inhalers (MDIs) of the kind often used for inhaled medication.
"Childhood asthma is a growing problem on both sides of the Atlantic and parents need reliable spacers to ensure their children get the right doses of asthmatic medication," said Dr Gerhard Scheuch, founder and ceo of Activaero.
"The Watchhaler makes supervision easier for the parent, inhalation more fun for the child and dosing of medication more controlled and accurate."