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# BrainQ AI for Stroke Gets Breakthrough Status
- URL: https://www.fdaweb.com/brainq-ai-for-stroke-gets-breakthrough-status/
- Published: 2021-02-12T12:00:00.000Z
- Updated: 2026-09-14T16:46:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148660

FDA has granted BrainQ’s artificial intelligence (AI)-powered technology for ischemic strokes a breakthrough device designation based on the company’s latest randomized controlled clinical trial results. BrainQ says it is developing the AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage caused by stroke. It is based on “biological insights retrieved from brainwaves, using proprietary machine learning algorithms that translate into a frequency-tuned low intensity electromagnetic field,” it says. BrainQ's therapy is delivered through a cloud-connected wearable device, the BQ System.