www.fdanews.com/articles/189964-fda-clears-sofregens-voice-augmenter
FDA Clears Sofregen’s Voice Augmenter
January 23, 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.