FDA grants Breakthrough Device Designation to earbud-like neuromodulation device for brain bleed recovery
By
Marta Wegorzewska
Summary
A non-invasive earbud-like neuromodulation device developed by Aurenar, a WashU startup, has received FDA Breakthrough Device Designation. The technology aims to prevent dangerous complications from brain bleeding (subarachnoid hemorrhage) in intensive care patients, specifically targeting delayed cerebral ischemia after a ruptured brain aneurysm. The device is based on clinical trials led by WashU Medicine physician-scientists including Dr. Eric Leuthardt, and works by stimulating the trigeminal nerve to improve blood flow and reduce brain damage.
Source
bskyFDA grants Breakthrough Device Designation to earbud-like neuromodulation device for brain bleed recoverymedicine.washu.eduKey quotes
· 3 pulledThe technology is based on clinical trials led by WashU Medicine physician-scientists including Eric Leuthardt, MD.
A non-invasive neuromodulation technology has received Breakthrough Device Designation from the FDA.
The earbud-like device from WashU startup Aurenar is designed to improve stroke outcomes after a ruptured brain aneurysm.
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