The Breakthrough Device designation, which comes after new trial data, is expected to expedite the device’s path to market.
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.
Stroke is one of the leading causes of disability, affecting 800,000 people every year in the United States alone. In the days and weeks following stroke, the brain attempts to repair damaged neural pathways and develop new ones to restore function, but often with limited success. This results in chronic disability for about 50-70% of survivors.
BrainQ is developing an AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage caused by stroke. The therapy is based on biological insights retrieved from brainwaves, using proprietary machine learning algorithms that translate into a frequency-tuned low intensity electromagnetic field. BrainQ’s therapy is delivered via a cloud-connected wearable device, the non-invasive BQ System, and is designed for scalable and portable treatment, with the flexibility to be accessed from home.
“We’re excited that the FDA has granted BrainQ a Breakthrough Device Designation,” said BrainQ CEO and Co-founder Yotam Drechsler. “Stroke is a debilitating condition with limited recovery options, creating a huge unmet need in the US. Covid-19 has only made things worse by limiting patients’ access to treatment facilities. FDA Breakthrough Designation is an important milestone in our mission to reduce disability for these patients and treat them in the comfort of their homes.”
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