Breakthrough Device Designation Granted to Brain-Monitoring Technology


The Food and Drug Administration has granted breakthrough device designation to a brain health monitoring technology (Neurametrix; San Francisco, CA). The approved use is monitoring Parkinson’s disease (PD) patients to enable more frequent treatment adjustments, which can be challenging for neurologists who typically see those patients only a few times a year. The digital biomarker in NeuraMetrix measures consistency of typing cadence—the rhythm of typing on a keyboard—which is a proven indicator of brain health. The technology enables neurologists to evaluate patients regularly, integrates quickly and easily into clinical practice, and can be rapidly adopted for screening large patient populations. 

Clinical data has demonstrated that NeuraMetrix may be effective for central nervous system diseases such as PD, Alzheimer’s disease, and depression. 

“The Breakthrough Device designation reaffirms that the NeuraMetrix brain monitoring solution could enable better treatment of patients by providing more precise and timely feedback,” said Jan Samzelius, chief executive officer of NeuraMetrix.  



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