Sonorous BosCath Neurovascular Catheter Cleared by FDA

April 22, 2026—Sonorous Neurovascular, a developer of solutions for cerebral venous diseases and neurovascular interventions, announced that it has received FDA 510(k) clearance for its BosCath, allowing the company to commercialize the next-generation neurovascular catheter in the United States.

According to the company, the BosCath is intended to enhance access, delivery, and procedural efficiency in complex cerebral venous and arterial anatomies. It is engineered for trackability, support, and navigability in challenging neurovascular procedures.

The company stated that the BosCath device is specifically designed to support the delivery of advanced therapies, such as its BosStent, in tortuous venous anatomy. BosStent is a braided self-expanding cerebral venous stent intended to treat symptomatic cerebral venous sinus stenosis associated with debilitating pulsatile tinnitus.

Earlier this year, the company announced FDA Breakthrough Device designation for BosStent.

Sonorous Neurovascular also advised that it has initiated the international B-SILENT study in France and Canada. B-SILENT will evaluate the investigational use of the BosStent for the treatment of debilitating pulsatile tinnitus caused by symptomatic cerebral venous sinus stenosis. The clinical study is intended to generate safety and performance data to support a future submission for CE Mark approval, noted the company.