FDA Gives Breakthrough Device Designation to Electromagnetic Field Therapy  for Potential  Reduction of Stroke Disability

The Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to an artificial intelligence-powered electromagnetic field therapy (BrainQ; Jerusalem, Israel) for potential treatment to reduce disability after neurologic damage caused by stroke. The device uses machine learning algorithms that translate into a frequency-tuned, low-intensity electromagnetic field delivered via a cloud-connected, wearable device that enables portable treatment. 

The designation was granted, in part, in response to results from a randomized clinical trial (NCT04039178) in people who had experienced ischemic stroke. The therapy is based on biological insights obtained from participants’ brainwaves. 

“We’re excited that the FDA has granted BrainQ a Breakthrough Device Designation,” said Yotam Drechsler, CEO and co-founder, BrainQ. “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.”