Akili Interactive Labs

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

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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

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

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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

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

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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

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

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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!

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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?

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LEARN MORE HERE

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?

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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).

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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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)