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.
Akili Interactive Labs
“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
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
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
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).
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)