Israeli BrainQ's artificial intelligence stroke therapy, which reduces disability following strokes, was given Breakthrough Device designation by the US Food and Drug Administration (FDA), the start-up announced last week. The designation will allow BrainQ to work with the FDA to expedite the development and clearance process of BrainQ's device.
Some 50 to 70% of those who suffer a stroke experience chronic disability in the aftermath of these events, according to BrainQ. BrainQ's AI-powered, electromagnetic field therapy aims to reduce disability caused by stroke through a non-invasive therapy.
BrainQ's therapy is designed to treat patients in the weeks and months following a stroke. Currently approved interventions for reducing disability following a stroke are only relevant in the first few hours following the stroke and only 5% of stroke victims reach the hospital in time to benefit from these, according to BrainQ, whose therapy aims to fill this gap.
The FDA designation as a breakthrough device is given to treatments that can "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”.
BrainQ's therapy is based on biological insights from brainwaves and uses machine learning algorithms that translate into frequency-tuned, low intensity electromagnetic fields. The therapy is delivered through a wearable device that is connected to the cloud. It is designed so that it is a portable treatment that can be used in the patient's home.
“Stroke is a debilitating condition with limited recovery options, creating a huge unmet need," said BrainQ CEO and Co-founder Yotam Drechsler.