Sonorous Neurovascular Receives FDA IDE Approval for First U.S. Pivotal Trial of a Venous Sinus Stent to Treat Pulsatile Tinnitus

RegulatoryapprovedB-SILENT 2Venous Sinus StentPositive

AI Analysis

Summary

Sonorous Neurovascular received FDA IDE approval to initiate B-SILENT 2, the first U.S. pivotal trial of a venous sinus stent for treating pulsatile tinnitus, expanding the company's international clinical program for its cerebral venous disease platform.

Clinical Trial Data

Phase

Pivotal

Outcome Details

FDA IDE Approval for First U.S. Pivotal Trial

Importance:7/10

Sentiment:

0.85

FDA approvalIDEmedical devicepivotal trialcerebral venous diseaseneurovascular

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Published by PR Newswire Biotech on October 7, 2026 12:53 PM

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