Brain/ Mental Health

Alto Neuroscience raises $60M (equity + credit) to help fix the “trial and error” approach to psychiatric medication

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Alto Neu­ro­science bags $25M for four Phase II drugs (End­points News):

Anoth­er $25 mil­lion is flow­ing the way of a Cal­i­for­nia biotech attempt­ing to fix the “tri­al and error” sys­tem in neu­ro­science drug R&D.

Alto Neu­ro­science picked up the cap­i­tal from Alpha Wave Ven­tures via an exten­sion to its Series B, bring­ing total equi­ty raised to $100 mil­lion since the startup’s 2019 found­ing. [Read more…] about Alto Neu­ro­science rais­es $60M (equi­ty + cred­it) to help fix the “tri­al and error” approach to psy­chi­atric medication

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

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)

Study identifies cognitive benefits of ketamine in patients with treatment-resistant depression

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Ket­a­mine mol­e­cules attach them­selves to NMDA neu­ronal recep­tors, which play an impor­tant role in brain plas­tic­i­ty and pre­dic­tive pro­cess­ing. C22H31NO2, CC BY-SA

Which fac­tors deter­mine what we believe about our world, our­selves, our past, and our future? Cog­ni­tive neu­ro­science sug­gests that our beliefs are depen­dent on brain activ­i­ty, specif­i­cal­ly on the way our brains process sen­so­ry infor­ma­tion in order to make sense of our environment.

These beliefs (defined as prob­a­bil­i­ty esti­mates) are cen­tral to our brain’s pre­dic­tive pro­cess­ing func­tion, which enables it to pre­dict the prob­a­bilis­tic struc­ture of the world around us. These pre­dic­tions could even be the fun­da­men­tal build­ing blocks of men­tal states, such as per­cep­tions and emotions.

Many psy­chi­atric dis­or­ders, such as depres­sion and schiz­o­phre­nia, are char­ac­terised by irreg­u­lar beliefs whose ori­gins we still don’t ful­ly under­stand. But if we can iden­ti­fy the cere­bral sys­tems gov­ern­ing them, we could tar­get those very areas in a bid to alle­vi­ate the pain asso­ci­at­ed to these ill­ness­es. [Read more…] about Study iden­ti­fies cog­ni­tive ben­e­fits of ket­a­mine in patients with treat­ment-resis­tant depression