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# FDA Breakthrough Status for Concussion Device
- URL: https://www.fdaweb.com/fda-breakthrough-status-for-concussion-device/
- Published: 2019-09-25T12:00:00.000Z
- Updated: 2026-09-15T01:52:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145095

FDA has granted Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating concussions. The device applies a near-infrared light to energize the brain’s metabolic cascade process and accelerate the healing process for concussions and other mild brain trauma. The company says it is currently completing animal safety trials to support human clinical trials and intends to begin its first human trials soon.