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

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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

Ballroom dancing can reduce aging-related brain atrophy in the hippocampus (and, more than treadmill walking!)

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Social ball­room danc­ing can improve cog­ni­tive func­tions and reduce brain atro­phy in old­er adults who are at increased risk for Alzheimer’s dis­ease and oth­er forms of demen­tia. That’s the key find­ing of my team’s recent­ly pub­lished study in the Jour­nal of Aging and Phys­i­cal Activity.

In our study, we enrolled 25 adults over 65 years of age in either six months of twice-week­ly ball­room danc­ing class­es or six months of twice-week­ly tread­mill walk­ing class­es. None of them were engaged in for­mal danc­ing or oth­er exer­cise pro­grams. [Read more…] about Ball­room danc­ing can reduce aging-relat­ed brain atro­phy in the hip­pocam­pus (and, more than tread­mill walking!)

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

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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

On cognitive-physical training, brain biomarkers, dementia, ketamine, brain teasers, riddles and more

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Wel­come to the last 2022 edi­tion of Sharp­Brains e‑newsletter, fea­tur­ing a few select­ed brain health news and fun teasers to chal­lenge your brain and help us all think out­side the box.

#1. “Every­one agrees that Google Glass failed when it came to mar­ket, but to me, it’s a sym­bol of hope … It inspired peo­ple to think beyond tra­di­tion­al ways of mov­ing about our envi­ron­ment. Instead of look­ing down at a device, we could look out at the world and have an over­lay of dig­i­tal infor­ma­tion. It was one of the first steps in physical–digital con­ver­gence that we are see­ing today through­out many indus­tries. And as some­one who has cre­at­ed many inven­tions that nev­er left the lab or were too ear­ly for the mar­ket, I love the fact that Glass came out at all!” — wise words by neu­rotech entre­pre­neur Dr. Cori Lath­an in her new (and excel­lent) book. See Tech­nol­o­gy as a bridge in time: Shap­ing the future of brain health via today’s innovations–including those that “fail”

#2. “Some peo­ple want to do cog­ni­tive train­ing while mov­ing rather than sit­ting down, and that real­ly spoke to me as a pos­si­bil­i­ty for real ben­e­fits giv­en anec­do­tal sto­ries about games like ‘Dance Dance Rev­o­lu­tion.’” — Joaquin A. Anguera, asso­ciate pro­fes­sor at UCSF and direc­tor of Neuroscape‘s Clin­i­cal Divi­sion. See Study: A com­bined cog­ni­tive-phys­i­cal train­ing approach may enhance both mind and body as we age

#3. “Giv­en that ketamine’s rapid action and unex­pect­ed dis­so­cia­tive effects make it a poten­tial­ly worth­while option for treat­ing men­tal health prob­lems, we are on a mis­sion to unpack this mys­tery, at the cross­roads between phar­ma­col­o­gy and neu­ro­science.” See Study iden­ti­fies cog­ni­tive ben­e­fits of ket­a­mine in patients with treat­ment-resis­tant depression

#4. “The grat­i­tude writ­ing group main­tained grat­i­tude lev­els and decreased stress and neg­a­tive affect at one-month post-inter­ven­tion” — that main­te­nance aspect is espe­cial­ly inter­est­ing. See Thanks­giv­ing works: Grat­i­tude jour­nal­ing seen to low­er stress and neg­a­tive cog­ni­tive processes

#5. Impres­sive new funding–especially giv­en mar­ket conditions–with a goal to iden­ti­fy “brain bio­mark­ers by ana­lyz­ing EEG activ­i­ty, behav­ioral task per­for­mance, wear­able data, genet­ics, and oth­er fac­tors to match each patient with the right Alto drug.” See Pre­ci­sion psy­chi­a­try pio­neer Alto Neu­ro­science rais­es $35M to advance dig­i­tal bio­mark­er-to-treat­ment platform

#6. Some bad news. See The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

#7. And some great news: “(Péter Hudomi­et, study’s lead author) said it’s also pos­si­ble that, giv­en numer­ous stud­ies being released on steps to take to avoid demen­tia, some of the decline may be attrib­uted to peo­ple heed­ing such advice.” See Study finds sharp decrease (near­ly one-third) in the preva­lence of demen­tia among those 65+ in the Unit­ed States

#8. Final­ly, here are a few brain teasers to stim­u­late those neu­rons in your tem­po­ral lobes and to help us all think out­side the box.

 

Have a healthy and won­der­ful 2023!

 

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

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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)

Technology as a bridge in time: Shaping the future of brain health via today’s innovations–including those that “fail”

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Remem­ber Google Glass? Google invest­ed mil­lions of dol­lars and came to mar­ket in 2014 with the first gen­er­a­tion of wear­able aug­ment­ed real­i­ty (AR) tech­nol­o­gy. You could wear their cool head­sets with or with­out glass­es and use them to read and send email all while going about oth­er tasks.

Even before it was avail­able to the pub­lic, Glass cre­at­ed a huge amount of buzz. In 2013, every­one want­ed to get in on beta testing.

Almost every keynote speak­er I saw that year would come out wear­ing a Google Glass headset—and then invari­ably admit the bat­tery had run out weeks ago and they were just wear­ing it to look cool. I have to admit, I did the same.

Maybe that’s because it made me nos­tal­gic for a prod­uct we had designed about ten years ear­li­er, in 2005. Our Visu­al­ly Inte­grat­ed Sen­sor Unit, or VISUnit, was an ear­ly ver­sion of an AR head­set. [Read more…] about Tech­nol­o­gy as a bridge in time: Shap­ing the future of brain health via today’s innovations–including those that “fail”