JERUSALEM, Feb. 11, 2021 /PRNewswire/ — BrainQ, the Israeli start-up with a therapeutic solution to reduce disability following stroke, announced today that the United States Food and Drug Administration (FDA) has designated its AI-powered technology as a Breakthrough Device. The designation, which was based on BrainQ’s latest randomized controlled clinical trial results for ischemic stroke patients, provides BrainQ with the opportunity to work closely with the FDA to expedite development plans and premarket clearance. Breakthrough status also gives BrainQ access to the new Medicare Coverage of Innovative Technology (MCIT) pathway, allowing for Medicare coverage to be provided concurrently with FDA market authorization.

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