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# TecTraum Pro2Cool is Breakthrough Device
- URL: https://www.fdaweb.com/tectraum-pro2cool-is-breakthrough-device/
- Published: 2021-11-03T12:00:00.000Z
- Updated: 2026-09-14T17:21:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150507

FDA has designated TecTraum’s Pro2cool System as a breakthrough device. The company [says](https://www.marketwatch.com/press-release/tectraums-pro2coolreceives-fda-designation-as-a-breakthrough-device-for-the-treatment-of-concussions-2021-11-03?tesla=y&ref=fdaweb.com) Pro2cool is a “novel, non-invasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their pre-injury baseline sooner. The device provides localized cooling for the head and neck to lower blood temperature before it enters the brain. Researchers have observed significant improvements in clinical outcomes through the cooling of the brain within days of the concussion.”

The company says it is nearing the completion of a large multi-site pivotal clinical trial to validate the effectiveness, safety, and tolerability of the system in patients between the ages of 12 and 21.