Sharp Brains: Brain Fitness and Cognitive Health News

Neuroplasticity, Brain Fitness and Cognitive Health News

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The FDA warns consumers not to use unapproved apps and devices to diagnose concussion

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FDA warns pub­lic not to use unap­proved or uncleared med­ical devices to help assess or diag­nose a con­cus­sion (news release):

Today, the U.S. Food and Drug Admin­is­tra­tion is warn­ing the pub­lic not to use med­ical devices mar­ket­ed to con­sumers that claim to help assess, diag­nose or man­age head injury, includ­ing con­cus­sion, trau­mat­ic brain injury (TBI) or mild TBI. Read the rest of this entry »

Problems grow for neuromodulation firm Helius Medical Technologies

Investor Alert: Kaplan Fox Inves­ti­gates Helius Med­ical Tech­nolo­gies, Inc. (press release):

NEW YORKFeb. 7, 2019 /PRNewswire/ — Kaplan Fox & Kil­sheimer LLP has been inves­ti­gat­ing claims on behalf of investors of Helius Med­ical Tech­nologiues, Inc. (“Helius” or the “Com­pa­ny”) (Nas­daq: HSDT).

On Jan­u­ary 22, 2019, after the mar­ket opened, White Dia­mond Research pub­lished Read the rest of this entry »

The FDA cracks down on dozens of supplements claiming to prevent or cure Alzheimer’s Disease

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FDA takes action against 17 com­pa­nies for ille­gal­ly sell­ing prod­ucts claim­ing to treat Alzheimer’s dis­ease (US Food & Drug Admin­is­tra­tion):

The U.S. Food and Drug Admin­is­tra­tion today post­ed 12 warn­ing let­ters and 5 online advi­so­ry let­ters issued to for­eign and domes­tic com­pa­nies that are ille­gal­ly sell­ing more than 58 prod­ucts, many that are sold as dietary sup­ple­ments, which are unap­proved new drugs and/or mis­brand­ed drugs that claim to pre­vent, treat or cure Alzheimer’s dis­ease Read the rest of this entry »

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) Read the rest of this entry »

Otsuka Pharma and Click Therapeutics enter partnership poised to transform mental healthcare

Otsu­ka, Click Ther­a­peu­tics part­ner to cre­ate ther­a­py for men­tal ill­ness (Ver­dict Med­ical Devices):

Otsu­ka Pharmaceutical’s US divi­sion Otsu­ka Amer­i­ca has part­nered with Click Ther­a­peu­tics to devel­op and com­mer­cialise a pre­scrip­tion dig­i­tal ther­a­peu­tic for treat­ing major depres­sive dis­or­der (MDD) Read the rest of this entry »

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters and more, SharpBrains is an independent market research firm tracking health and performance applications of brain science.

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