Serenity Medical Receives FDA Breakthrough Device Designation for Shepherd Stent System

Regulation
โดย GlobeNewswire·Read original
Summary · why it matters

Serenity Medical has received U.S. FDA Breakthrough Device Designation for its Serenity Shepherd Stent System to treat severe pulsatile tinnitus. The stent system is designed to navigate the cerebral sinuses and address venous sinus stenosis, a condition that can cause debilitating pulse-synchronous sound leading to depression and impaired quality of life. This designation follows the FDA HDE approval of Serenity's River Stent for idiopathic intracranial hypertension earlier this year, marking the company's second consecutive FDA milestone. The Breakthrough Device Designation provides an expedited review pathway for technologies that offer more effective treatment for life-threatening or irreversibly debilitating conditions. Serenity Medical is a NeuroTechnology Investors portfolio company, and its commercial partner Radical Catheter Technologies is positioned to support rapid market adoption through specialized neurovascular infrastructure.

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Off-coverage companies 3

Serenity MedicalPrivate▲ Positive
Regulationrelevance

Serenity Medical received FDA Breakthrough Device Designation for its Shepherd Stent System, expediting review.

Radical Catheter TechnologiesPrivate▲ Positive
Demandrelevance

Radical Catheter Technologies is the commercial partner, positioned to support market adoption of the Shepherd Stent System.

NeuroTechnology InvestorsPrivate▲ Positive
Capitalrelevance

Serenity Medical is a portfolio company, so the FDA designation may increase the value of NeuroTechnology Investors' stake.

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