Syncardia Nabs Two Humanitarian Use Device Wins for Its Smaller Artificial Heart
The FDA approved 2 new HUD designations for SynCardia's 50cc Total Artificial Heart device for use in children, smaller women and people with small stature.
SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device.
The new HUD designations apply to use with children, smaller women and other people with small stature. The Tuscon, Ariz.-based device manufacturer designed this device as a smaller version of its 70cc temporary Total Artificial Heart, approved in 2004, according to a press release.