VS3 Medical Receives FDA Breakthrough Device Designation for VS3 System to Treat Debilitating Pulsatile Tinnitus
September 29, 2026
VS3 Medical, a private company developing novel neurovascular implants, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its VS3 System. The designation is based on evidence demonstrating that the system has the potential to resolve debilitating pulsatile tinnitus due to venous sinus stenosis.
“Advances in imaging have significantly improved our understanding of the intracranial venous anatomy, enabling the development of technologies like ours that are designed to specifically address the underlying anatomical causes of symptomatic venous sinus stenosis.”
Matthew Amans, M.D., M.S.,