FDA News Briefs for Monday, July 30, 2018July 30, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Grants De Novo Marketing Clearance for Bonebridge Hearing Implant System
The FDA has granted de novo marketing clearance for the Bonebridge bone conducting hearing implant system (Med-El USA). The system is indicated for individuals aged 12 years and older with conductive hearing loss, mixed hearing loss, or single-sided deafness. More Information.
FDA Update on Valsartan Recalls
The FDA has issued an update regarding recalled valsartan-containing products. Not all products containing valsartan are being recalled; this update clarifies which valsartan-containing products are being recalled. More Information.