The FDA has granted Canica Design premarket approval for its DynaCleft system, a presurgical treatment for infants with cleft lip and palate. The device employs an elastomeric band to connect the cleft segments and has been shown in a clinical study to be comparable to the nasoalveolar molding intraoral appliance frequently used as a presurgical therapy option.
Cleft palate device from Canica Design gains FDA OK
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