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www.fdanews.com/articles/175431-fda-awards-510-k-clearance-to-hospitechs-anapnoguard

FDA Awards 510 (k) Clearance to Hospitech’s AnapnoGuard

February 22, 2016

Israel’s Hospitech Respiration has scored FDA clearance for its AnapnoGuard 100 system for airway management.

The device — which is intended for continuous, closed-loop control of trachea sealing and endotracheal cuff pressure — is CE cleared.

AnapnoGuard combines regulation of cuff pressure based on carbon dioxide concentration with the evacuation of subglottic secretions to deliver continuous breathing support. — Anisa Jibrell