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Medical Devices / Submissions and Approvals

FDA Clears Sofregen’s Voice Augmenter

Jan. 24, 2019

The FDA granted Sofregen’s silk protein-based injectable filler device, the Silk Voice, 510(k) clearance.

Designed to augment a patient’s vocal fold tissue and improve phonation, the device is made from solubilized silk protein. It was developed in collaboration with leading laryngologists.

The device uses a proprietary single-use catheter delivery system for injection.

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