Israeli stroke therapy granted FDA breakthrough device status
“Stroke is a debilitating condition with limited recovery options, creating a huge unmet need."
By Jerusalem Post Staff, February 15, 2021
BrainQ's artificial intelligence stroke therapy. (photo credit: BRAINQ)
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 artificial intelligence stroke therapy. (photo credit: BRAINQ) https://brainqtech.com/ |
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”.
AI Tech for Neuro-Disorders: BrainQ | Google for Startups Accelerator, Dec. 28,2018
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.
"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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