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Akili Interactive Labs

FDA clears first videogame to be prescribed to kids with ADHD: EndeavorRx by Akili Interactive Labs

June 18, 2020 by SharpBrains

Screen­shot of EndeavorRx

In a land­mark deci­sion, FDA green­lights a video game for kids with ADHD (STAT):

The Food and Drug Admin­is­tra­tion on Mon­day for the first time gave a green light to a game-based ther­a­peu­tic: a video game meant to be pre­scribed to kids with ADHD.

The game, known as Endeav­or­Rx and devel­oped by Boston-based Akili Inter­ac­tive Labs, can now be mar­ket­ed as a way to improve atten­tion func­tion in kids with ADHD as mea­sured by com­put­er­ized test­ing. Physi­cians can pre­scribe it to chil­dren between the ages of 8 and 12 who have an ADHD diag­no­sis and have demon­strat­ed an issue with attention.

The FDA’s move is a land­mark deci­sion in the emerg­ing dig­i­tal ther­a­peu­tics sec­tor: In addi­tion to being the first game to be mar­ket­ed as a ther­a­py for any type of con­di­tion, Endeav­or­Rx is the first dig­i­tal ther­a­peu­tic meant to improve symp­toms asso­ci­at­ed with ADHD, the FDA’s announce­ment said…The game was born in the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co lab of neu­ro­sci­en­tist Adam Gaz­za­ley, and was licensed out by Akili, which pol­ished and test­ed the game in clin­i­cal tri­als. Akili spent the past two years wait­ing on a reg­u­la­to­ry deci­sion from the FDA.

[Read more…] about FDA clears first videogame to be pre­scribed to kids with ADHD: Endeav­or­Rx by Akili Inter­ac­tive Labs

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: 510(k), Adam Gazzaley, adhd, Akili Interactive Labs, computerized testing, De Novo, digital therapeutics, EndeavorRx, FDA, game-based therapeutic, TOVA, videogame

Large study finds positive yet mixed results from Akili’s digital therapeutic for kids with ADHD

February 25, 2020 by SharpBrains

__

Full pub­li­ca­tion of piv­otal tri­al data out­lines Akil­i’s case for FDA reg­u­la­tion (Mobi­Health­News):

“A full tran­script of STARS-ADHD — the piv­otal tri­al of Akili Interactive’s video game-like pedi­atric atten­tion deficit treat­ment — has been pub­lished in The Lancet Dig­i­tal Health jour­nal, pro­vid­ing onlook­ers a clear view of data fuel­ing the dig­i­tal ther­a­peu­tic company’s pend­ing FDA sub­mis­sion [Read more…] about Large study finds pos­i­tive yet mixed results from Akili’s dig­i­tal ther­a­peu­tic for kids with ADHD

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Filed Under: Attention & ADD/ADHD, Brain/ Mental Health, Technology & Innovation Tagged With: adhd, ADHD-medication, Akili, Akili Interactive, Akili Interactive Labs, AKL-T01, behavioral, cognitive, digital health, digital therapeutics, pediatric ADHD, Project EVO, TOVA API, treatment, video-games

How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD

July 23, 2019 by SharpBrains

How to address pri­va­cy, eth­i­cal and reg­u­la­to­ry issues: Exam­ples in cog­ni­tive enhance­ment, depres­sion and ADHD from Sharp­Brains

We hope you enjoy this slid­edeck sup­port­ing a great ses­sion at the 2019 Sharp­Brains Vir­tu­al Sum­mit: The Future of Brain Health (March 7–9th).  Full record­ings are avail­able for pur­chase here.

1–2.30pm. How to address pri­va­cy, eth­i­cal and reg­u­la­to­ry issues: Exam­ples in cog­ni­tive enhance­ment, depres­sion and ADHD 

  • Dr. Karen Rom­melfanger, Direc­tor of the Neu­roethics Pro­gram at Emory University
  • Dr. Anna Wexler, Assis­tant Pro­fes­sor at the Perel­man School of Med­i­cine at UPenn
  • Jacque­line Stud­er, Senior VP and Gen­er­al Coun­sel of Akili Inter­ac­tive Labs
  • Chaired by: Kei­th Epstein, Health­care Prac­tice Leader at Blue Heron

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: adhd, Akili Interactive Labs, Blue Heron, cognitive-enhancement, depression, Emory-University, ethics, Neuroethics, privacy, UPenn

10+ pioneers confirmed to Speak @ 2019 SharpBrains Virtual Summit (May 7–9th)

February 19, 2019 by SharpBrains

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We are proud to announce the first wave of con­firmed Speak­ers to share their inno­v­a­tive work and insights at the 2019 Sharp­Brains Vir­tu­al Sum­mit: The Future of Brain Health, to be held May 7–9th, 2019:

Dr. Tom Insel, Co-founder and Pres­i­dent of Mind­strong Health
Dr. Ainslie Hatch, Direc­tor of Dig­i­tal Ther­a­peu­tics at Otsu­ka Pharmaceutical
David Klein, CEO of Click Ther­a­peu­tics
Char­lie Hartwell, Oper­at­ing Part­ner at The Bridge Builders Collaborative
Louis Gagnon, CEO of Total Brain
Dr. Anna Wexler, sci­ence writer and PI of the Wexler Lab at UPenn
Dr. Eddie Mar­tuc­ci, Founder and CEO of Akili Inter­ac­tive Labs
Ana Maiques, CEO of Neu­ro­electrics
Jan Samzelius, Founder and CEO of Neu­raMetrix
Dr. Peter White­house, Pro­fes­sor of Neu­rol­o­gy at Case West­ern Reserve University
Kito Toset­ti, CEO of CTF MEG International
Ariel Garten, Founder and Chief Evan­ge­lism Offi­cer of Inter­aX­on
Alvaro Fer­nan­dez, CEO and Edi­tor-in-Chief of Sharp­Brains

We can’t wait to discuss and help shape the Future of Brain Health!

_______________

Imag­ine your smart­phone can detect ear­ly signs of anx­i­ety, depres­sion or Parkinson’s Dis­ease — would you like to know? Who else should know … and not know?

Imag­ine a videogame cleared by the FDA to treat ADHD or sub­stance abuse — how will doc­tors pre­scribe it, patients access it, and insur­ers pay for it?

Imag­ine being respon­si­ble for the health & well­ness of your orga­ni­za­tion — how will you nav­i­gate the grow­ing toolk­it of evi­dence-based inter­ven­tions such as exercise/ meditation/ sleep apps/ cog­ni­tive therapies/ biofeedback/ tDCS?

Imag­ine invest­ing $100 mil­lion to help accel­er­ate brain research and appli­ca­tions — how would you ensure that respon­si­ble devel­op­ment meets wise adop­tion?

Imag­ine a free annu­al brain check-up — who should take it, and how could it help prevent/ delay/ treat cog­ni­tive decline and Alzheimer’s Disease?

_______________

LEARN MORE HERE

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Akili Interactive Labs, Bridge Builders Collaborative, Case-Western-Reserve-University, Click Therapeutics, CTF MEG International, Interaxon, Mindstrong Health, NeuraMetrix, Neuroelectrics, Otsuka Pharmaceutical, sharpbrains, Total Brain, Wexler Lab

How will the Clinicians, Patients and Consumers of the Future ensure appropriate use of brain enhancement methods encompassing lifestyle, supplements, brain training, meditation, bio/ neurofeedback, tDCS and more?

December 27, 2017 by SharpBrains

How will the Clin­i­cians, Patients and Con­sumers of the Future ensure appro­pri­ate use of brain enhance­ment meth­ods encom­pass­ing lifestyle, sup­ple­ments, brain train­ing, med­i­ta­tion, bio/ neu­ro­feed­back, tDCS and more? (record­ing requires reg­is­tra­tion; view slid­edeck above or Here)

  • Dr. Eddie Mar­tuc­ci, Co-Founder and CEO of Akili Inter­ac­tive Labs
  • Dr. Anna Wexler, sci­ence writer, film­mak­er and post­doc fel­low at the Depart­ment of Med­ical Ethics and Health Pol­i­cy at UPenn’s Perel­man School of Medicine
  • Dr. Olivi­er Oul­li­er, Pres­i­dent of EMOTIV 
  • Dr. Peter Rein­er, Co-Founder of the Nation­al Core for Neu­roethics at the Uni­ver­si­ty of British Columbia
  • Chaired by: Dr. Ali­son Fen­ney, Exec­u­tive Direc­tor of the Neu­rotech­nol­o­gy Indus­try Orga­ni­za­tion (NIO)

Slid­edeck above sup­port­ed ses­sion held dur­ing the 2017 Sharp­Brains Vir­tu­al Sum­mit: Brain Health & Enhance­ment in the Dig­i­tal Age (Decem­ber 5–7th).

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Akili, Akili Interactive Labs, brain-enhancement, Brain-Training, Clinicians, Consumers, Emotiv, ethics, future, lifestyle, meditation, Neuroethics, Neurofeedback, NIO, patients, supplements, tDCS, UBC, UPenn

Dr. Anna Wexler to discuss the Present and Future of DIY Brain Enhancement at the 2017 SharpBrains Virtual Summit (December 5–7th)

November 8, 2017 by Alvaro Fernandez

_____

Proud to con­firm that Dr. Anna Wexler, a sci­ence writer, film­mak­er and post­doc fel­low in advanced bio­med­ical ethics at the Depart­ment of Med­ical Ethics & Health Pol­i­cy at the Uni­ver­si­ty of Penn­syl­va­nia, will dis­cuss the Present and Future of DIY Brain Enhance­ment (espe­cial­ly brain stim­u­la­tion modal­i­ties such as tDCS) at the upcom­ing 2017 Sharp­Brains Vir­tu­al Sum­mit.

Her research cen­ters on the eth­i­cal, legal and social impli­ca­tions of emerg­ing neu­rotech­nol­o­gy. Dr. Wexler received [Read more…] about Dr. Anna Wexler to dis­cuss the Present and Future of DIY Brain Enhance­ment at the 2017 Sharp­Brains Vir­tu­al Sum­mit (Decem­ber 5–7th)

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Akili Interactive Labs, Anna Wexler, biomedical, biomedical ethics, brain-enhancement, brain-stimulation, DIY, DIY Brain Enhancement, Emotiv, ethics, Neuroethics, Neurotechnology, noninvasive, noninvasive brain stimulation, tDCS

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