Israeli start-up BrainQ has secured breakthrough device status from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based device to reduce disability following stroke.
The breakthrough device status has been provided for the device based on the latest randomised controlled clinical trial results for ischemic stroke patients.
BrainQ is developing an AI-powered electromagnetic field therapy to boost recovery and minimise disability after neurological damage caused by stroke.
The therapy, which is based on biological insights fetched from brainwaves, uses advanced machine learning algorithms to convert into a frequency-tuned low intensity electromagnetic field.
The non-invasive BQ system is a cloud-connected wearable device that helps to deliver BrainQ’s therapy. Providing a flexibility for access at home, the device facilitates scalable and portable treatment.
BrainQ CEO and co-founder Yotam Drechsler said: “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.”
With currently-approved interventions to reduce disability are relevant only in the first few hours after stroke, only those arriving at the hospital in time will benefit from the treatments.
By offering a therapy that is designed for use in the days and weeks following stroke, BrainQ targets to extend the treatment opportunity from the acute phase to the sub-acute phase.
The company is carrying out clinical trials in major medical centres across the world and has received patents in all major global markets.
Last month, Functional Neuromodulation secured FDA breakthrough device status for Vercise deep brain stimulation (DBS) system to treat Alzheimer’s disease.
