Sharp Brains: Brain Fitness and Cognitive Health News

Neuroplasticity, Brain Fitness and Cognitive Health News


An idea gaining traction: Can measuring typing cadence help monitor and treat Parkinson’s Disease?

FDA grants break­through device des­ig­na­tion to Neu­raMetrix (press release):

The U.S. Food and Drug Admin­is­tra­tion (FDA) has grant­ed Break­through Device des­ig­na­tion to the Neu­raMetrix brain health mon­i­tor­ing solu­tion. The des­ig­na­tion is grant­ed for devices “that pro­vide more effec­tive treat­ment or diag­no­sis of life-threat­en­ing or irre­versibly debil­i­tat­ing human dis­ease or con­di­tions”. The approved use is mon­i­tor­ing of Parkinson’s dis­ease (PD) to more effec­tive­ly treat patients with PD, which is a sig­nif­i­cant chal­lenge for neu­rol­o­gists today as they only see the patient a few times a year. 

PD is a debil­i­tat­ing chron­ic con­di­tion that affects hun­dreds of thou­sands of lives glob­al­ly. Although there is no cure for PD, ear­ly detec­tion, dis­ease man­age­ment and prop­er treat­ment can pro­vide sig­nif­i­cant relief. “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.

The Neu­raMetrix’ dig­i­tal bio­mark­er mea­sures incon­sis­ten­cy of typ­ing cadence (the rhythm of how we type on a key­board) — a proven indi­ca­tor of brain health. Clin­i­cal data has demon­strat­ed that Neu­raMetrix may be effec­tive for Cen­tral Ner­vous Sys­tem (CNS) dis­eases such as PD, Alzheimer’s dis­ease (AD) and Depres­sion.”

About the Breakthrough Devices Program

  • Descrip­tion: The Break­through Devices Pro­gram is a vol­un­tary pro­gram for cer­tain med­ical devices and device-led com­bi­na­tion prod­ucts that pro­vide for more effec­tive treat­ment or diag­no­sis of life-threat­en­ing or irre­versibly debil­i­tat­ing dis­eases or con­di­tions … The Break­through Devices Pro­gram replaces the Expe­dit­ed Access Path­way and Pri­or­i­ty Review for med­ical devices. The FDA con­sid­ers devices grant­ed des­ig­na­tion under the Expe­dit­ed Access Path­way to be part of the Break­through Devices Pro­gram.
  • To learn more, vis­it the FDA page Here

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Categories: Cognitive Neuroscience, Health & Wellness, Technology

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