Aurenar’s V-Link earned FDA breakthrough device designation after early trials showed it reduced cerebral vasospasm by more than 40%, targeting complications tied to brain hemorrhage. The company’s non-invasive nerve stimulation device is positioned as an intervention that could help prevent post-hemorrhagic deterioration by limiting vasospasm risk. FDA breakthrough designation highlights potential for faster development and interaction with regulators when additional evidence is gathered. Aurenar’s designation adds momentum to neurostimulation platforms that aim to broaden access beyond invasive procedures, with early biomarker-oriented outcomes central to the justification. Clinically, the breakthrough label signals attention to timing, patient selection, and endpoints tied to cerebrovascular complications as the next evidence threshold for broader use.