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Technology & Innovation

The European Society for Brain Stimulation opposes EU reclassification of TMS and tDCS, claiming a flawed safety assessment

January 24, 2023 by SharpBrains Leave a Comment

Man­i­festo: Oppo­si­tion to EU Reclas­si­fi­ca­tion of TMS and tDCS equip­ment to Class III devices based on flawed evi­dence (Euro­pean Soci­ety for Brain Stimulation):

It has recent­ly come to our atten­tion that the EU has reclas­si­fied the NIBS equip­ments includ­ing rTMS and tDCS, as Class III devices, the cat­e­go­ry of high­est risk, sim­i­lar to inva­sive treat­ments, such as deep-brain stim­u­la­tion implants. This reclas­si­fi­ca­tion has a major impact on our field, not only for man­u­fac­tur­ers, but also for researchers, clin­i­cians and patients and we judge this reclas­si­fi­ca­tion a mis­take. First, the evi­den­tial basis for this change is a flawed assess­ment of the safe­ty lit­er­a­ture. Sec­ond, the con­sul­ta­tion process has occurred with­out input from spe­cial­ists or stake­hold­ers pro­fes­sion­al­ly active in the field of NIBS. Nei­ther the ESBS nor Nation­al Soci­eties of Brain Stim­u­la­tion nor indi­vid­ual experts with­in the Euro­pean NIBS com­mu­ni­ty were con­sult­ed on this change. [Read more…] about The Euro­pean Soci­ety for Brain Stim­u­la­tion oppos­es EU reclas­si­fi­ca­tion of TMS and tDCS, claim­ing a flawed safe­ty assessment

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: brain stimulation, EU, European Society for Brain Stimulation, neurostimulation, rTMS, tDCS

Voice biomarker platform Sonde Health raises $19.25M to spread access to mental health monitoring and beyond

January 5, 2023 by SharpBrains Leave a Comment

Voice analy­sis plat­form Sonde Health rais­es $19.25M (Mobi­Health­News):

AI-enabled voice tech­nol­o­gy plat­form Sonde Health announced it raised $19.25 mil­lion in a Series B fund­ing round led by Part­ners Invest­ment, bring­ing its total raise to $35.25 mil­lion … Sonde Health uses patent­ed voice tech­nol­o­gy to detect var­i­ous health con­di­tions from bio­mark­ers in a per­son­’s voice, includ­ing ana­lyz­ing res­pi­ra­to­ry fit­ness and detect­ing depres­sion and anx­i­ety. [Read more…] about Voice bio­mark­er plat­form Sonde Health rais­es $19.25M to spread access to men­tal health mon­i­tor­ing and beyond

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: anxiety, biomarkers, depression, health monitoring, mental-fitness, Sonde Health, vocal biomarkers

The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

December 20, 2022 by SharpBrains Leave a Comment

FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus):

The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency ear­ly on that it lacked the legal author­i­ty to ful­ly imple­ment pathway.

In 2017, the FDA pro­posed the idea of a Pre-Cert pro­gram that would act as a new path­way for soft­ware as a med­ical device (SaMD) prod­ucts, through which the agency could green-light such prod­ucts based on how much reg­u­la­tors trust the man­u­fac­tur­er. The agency has been run­ning a pilot pro­gram to test the fea­si­bil­i­ty of the pro­gram, but in a new report, FDA con­cedes it does not have the legal author­i­ty need­ed to cre­ate the pro­gram as orig­i­nal­ly envi­sioned. [Read more…] about The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: digital health, FDA, Pre-Cert, precertification, software as a medical device, US Food and Drug Administration

Precision psychiatry pioneer Alto Neuroscience raises $35M to advance digital biomarker-to-treatment platform

November 7, 2022 by SharpBrains Leave a Comment

Alto Neu­ro­science Rais­es $35M Series B Financ­ing (Fins­Mes):

Alto Neu­ro­science, a Los Altos, CA-based neu­ro-tech com­pa­ny which spe­cial­izes in pre­ci­sion psy­chi­a­try, rais­es $35M Series B Financ­ing … The com­pa­ny intends to use the funds to advance lead can­di­dates into Phase 2b stud­ies in major depres­sive dis­or­der … Pro­ceeds from the financ­ing will also be used to progress the company’s arti­fi­cial intel­li­gence-enabled brain bio­mark­er plat­form and launch new clin­i­cal tri­als in areas of high unmet med­ical need. Alto will report Phase 2a data in ear­ly 2023 and fur­ther antic­i­pates Phase 2b data read­outs by ear­ly 2024. [Read more…] about Pre­ci­sion psy­chi­a­try pio­neer Alto Neu­ro­science rais­es $35M to advance dig­i­tal bio­mark­er-to-treat­ment platform

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Alto Neuroscience, Amit Etkin, artificial intelligence, brain biomarker, EEG activity, Major Depressive Disorder, neuro-tech, precision psychiatry

On cognitive training, muscle mass, neurostimulation, brain teasers, apps, and more

October 31, 2022 by SharpBrains Leave a Comment

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & inno­va­tion news and a few fun teasers to test your work­ing memory.

#1. Study: Build­ing mus­cle mass helps delay cog­ni­tive decline beyond the val­ue of exer­cise itself

“Teas­ing out exact­ly how mus­cle helps the brain remains a chal­lenge. There are plen­ty of indi­rect links … But Dr. Chevalier’s results sug­gest there may be more direct mech­a­nisms too. One pos­si­bil­i­ty is the role of myokines, a set of hor­mone-like mol­e­cules pro­duced by mus­cle cells that can trav­el to the brain and influ­ence mood, learn­ing and oth­er cog­ni­tive func­tions. Greater mus­cle mass may also help keep blood glu­cose lev­els in check, pro­tect­ing the brain from damage.”

#2. Clin­i­cians and aca­d­e­mics should engage users when review­ing apps, study finds

“More than half of the app rat­ings showed dis­agree­ment between par­tic­i­pants and pro­fes­sion­als … Par­tic­i­pants par­tic­u­lar­ly val­ued cer­tain aspects of men­tal health apps, which appear to be over­looked by pro­fes­sion­al review­ers. These includ­ed func­tions such as the abil­i­ty to track and mea­sure men­tal health and pro­vid­ing gen­er­al men­tal health edu­ca­tion. The cost of apps was among the most impor­tant fac­tors for participants.”

#3. Com­bined tDCS neu­rostim­u­la­tion and cog­ni­tive train­ing found to improve work­ing mem­o­ry among old­er adults–especially those with low­er start­ing capacity

“… indi­vid­ual char­ac­ter­is­tics influ­enced the out­come of com­bined cog­ni­tive train­ing and tDCS reg­i­mens, with the inter­ven­tion selec­tive­ly ben­e­fit­ing old-old adults with low­er work­ing mem­o­ry capac­i­ty. Future work should con­sid­er devel­op­ing indi­vid­u­al­ized treat­ments by con­sid­er­ing indi­vid­ual dif­fer­ences in cog­ni­tive profiles.”

#4. Head­space Health’s Leslie Witt on the future of men­tal health

“I fun­da­men­tal­ly believe in the pow­er of mind­ful­ness and med­i­ta­tion tools, but they can’t serve all men­tal health needs. And par­tic­u­lar­ly when someone’s in a state of acute anx­i­ety, acute depres­sion, they need access to pro­fes­sion­al, human services…We are build­ing out what I often call the mid­dle piece, the bridge that exists between the self-serve con­tent in the Head­space app and the text-based coach­ing, telether­a­py and telepsy­chi­a­try of the Gin­ger service.”

#5. Study: Prac­tic­ing grat­i­tude helps low­er phys­i­o­log­i­cal stress lev­els of the “express­er” AND the “receiv­er”

“The impli­ca­tion here is that you should let your grat­i­tude out when you feel it … That’s not to say that you should go around and make up grat­i­tude expres­sions for no rea­son. But, when you gen­uine­ly feel grat­i­tude, you should express it.” — Christo­pher Oveis, Direc­tor of the Empa­thy & Emo­tion Lab at UCSD

#6. Tak­ing your brain vitals: Sto­ries from a tech­no-opti­mist invent­ing the future of human performance

“My vision for DANA has always been that every time you go to the doc­tor, in addi­tion to tak­ing your height, weight, blood pres­sure, and tem­per­a­ture, they will take your DANA brain vital. When mea­sur­ing your brain health becomes sec­ond nature—as com­mon as check­ing your blood pressure—it will empow­er every­one, no mat­ter their age, to spot changes soon­er and take action.” — Cori Lath­an, CEO of Anthro­Tron­ix, in her great new book.

#7. UK agen­cies to review and update reg­u­la­tion of dig­i­tal men­tal health tools

Time­ly and impor­tant work to be done by the Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) and the Nation­al Insti­tute for Health and Care Excel­lence (NICE).

#8. Last but not least, let us share a few quick brain teasers to exer­cise your work­ing mem­o­ry … enjoy!

 

Wish­ing you and yours a healthy and warm month of November

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Filed Under: Brain Teasers, Brain/ Mental Health, SharpBrains Monthly eNewsletter, Technology & Innovation Tagged With: app ratings, Brain Teasers, brain vitals, cognitive decline, cognitive profiles, Cognitive-functions, Cognitive-Training, DANA brain vital, digital mental health, exercise, Ginger, Gratitude, Headspace, mental health apps, muscle mass, regulation, tDCS neurostimulation, Working-memory

Combined tDCS neurostimulation and cognitive training found to improve working memory among older adults–especially those with lower starting capacity

October 25, 2022 by SharpBrains Leave a Comment

Giv­ing mem­o­ry a lift: Can games and brain stim­u­la­tion do it? (Med­ical­New­sTo­day):

A person’s work­ing mem­o­ry may decline with age or if they have demen­tia, Parkinson’s dis­ease, or have had a stroke. When this occurs, the loss can affect their day-to-day qual­i­ty of life, turn­ing even sim­ple tasks into often-demor­al­iz­ing chal­lenges. [Read more…] about Com­bined tDCS neu­rostim­u­la­tion and cog­ni­tive train­ing found to improve work­ing mem­o­ry among old­er adults–especially those with low­er start­ing capacity

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: aging, brain stimulation, Brain-Plasticity, COGNISANT, cognitive needs, cognitive-functioning, cognitive-skills, Cognitive-Training, dementia, dorsolateral prefrontal cortex, neuroplasticity, Parkinsons-disease, prefrontal-cortex, strengthen working memory, tDCS, Transcranial-direct-current-stimulation, Working-memory, working-memory-training

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