Aurenar’s V-Link, a non-invasive nerve stimulation device intended to prevent cerebral vasospasm after brain hemorrhage, received FDA breakthrough device designation after early trials showed it reduced cerebral vasospasm by more than 40%. The designation advances the company’s development pathway for a device aimed at preventing neurologic complications. V-Link uses ear-based stimulation to affect nerve signaling involved in post-hemorrhage vascular changes. The breakthrough designation can shorten FDA review timelines and supports broader clinical evaluation. For biotech and med-tech stakeholders, the designation highlights continued regulatory appetite for mechanism-targeted, non-drug interventions that address high-risk complications rather than underlying disease alone.