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# FDA Clears Next-Gen IQool Warm System
- URL: https://www.fdaweb.com/fda-clears-next-gen-iqool-warm-system/
- Published: 2018-05-29T12:00:00.000Z
- Updated: 2026-09-15T00:08:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141548

FDA has cleared a BrainCool 510(k) for the IQool Warm System, intended for use to provide thermal regulation to cool and rewarm adult patients when clinically indicated. The company says the device adds a new feature to its 2017 originally cleared device — to cool patients using its anatomically targeted temperature regulation pads. The surface temperature regulation system is intended for use on the head/neck, thigh and torso. It works by applying non-stick adhesive pads prefilled with BCCOOL (a non-toxic and bacteriostatic cooling agent) that are attached to an automated temperature control unit, it says.