Akili

By Dave Muoio 05:39 pm June 15, 2020
After years of waiting, Akili Interactive has finally received FDA De Novo marketing authorization for EndeavorRx, its video-game digital therapeutic for children aged 8 to 12 years with ADHD. This is the first game-based therapeutic that the FDA has greenlit for any condition, the regulatory agency noted in its announcement. It is also the first authorization for Akili, which has a handful of...
By Dave Muoio 06:00 am April 22, 2020
Less than a week after FDA opened the faucet for digital health products treating psychiatric conditions during the COVID-19 health crisis, Akili has fast-tracked and released its approval-pending digital therapeutic for children with ADHD. Now known as Endeavor and flanked by a symptom tracker and caretaker support line, the video game-like app will be provided at no cost for a limited time to...
By Dave Muoio 07:50 pm February 24, 2020
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. The writeup echoes topline findings first unveiled by the company in December 2017: compared to a...
By Dave Muoio 02:00 pm January 15, 2020
Editor's note: The original version of this story claimed that STARS-ADHD Adjunctive enrolled 2016 subjects, instead of 206. We apologize for this error. Digital therapeutic company Akili Interactive has announced the first results of an open-label, multisite pediatric ADHD trial providing some patients with the company’s video game-like treatment alongside a stimulant medication. Called the ...
By Laura Lovett 03:48 pm December 12, 2019
A video game-like digital therapy may be key to helping reduce cognitive impairments in adults living with major depressive disorder (MDD).  Results out of a new study conducted by Akili interactive found that patients using the company’s AKL-T03 significantly improved their sustained attention compared to their peers in the control group.  In the study, which was presented at the Meeting of the...
By Dave Muoio and Laura Lovett 03:45 pm September 27, 2019
It’s been two years since the first software-only digital therapeutic got the FDA greenlight, but the industry is still very much in its infancy and continuing to evolve. New entrances are emerging from the world of health, pharma, tech and finance. As the industry matures, it's grappling with existential questions including regulation, reimbursement models and, as always, the definition of a...
By Laura Lovett 04:22 pm September 25, 2019
There’s no denying that digital therapeutics look and feel different than traditional medications. Instead of popping open a medication bottle, users are logging into an app to access treatment. But the differences don’t stop at the look. While the risk of toxicity is an ever-looming question in the pharma space, the same isn’t true for digital solutions.  Stakeholders at the digital therapeutics...
By Dave Muoio 03:38 pm March 7, 2019
Boston-based Akili Interactive Labs, maker of video game-like treatments for children with ADHD and autism spectrum disorder, has found a partner to help promote its digital therapeutic products in eastern Asia. Thanks to a new strategic partnership announced this morning, Osaka, Japan-based pharmaceutical company Shionogi will take over the commercialization, marketing, clinical development and...

Left to right: Dr. Daniel Kraft, Fitbit's Any McDonough, Verily's Dr. Jess Mega and Akili's Eddie Martucci chat on stage at CES 2019’s Digital Health Summit

By Dave Muoio 12:05 pm January 9, 2019
Digital therapeutics are a nascent corner of the healthcare technology industry. With few precedents available outside of novel drugs or medical devices, it would make sense that Pear Therapeutics, Proteus and other digital therapeutics companies furthest along the regulatory pipeline align themselves with industry partners well versed in selling and supporting a medical product. As such, it came...
By Dave Muoio 03:51 pm January 3, 2019
A small feasibility study conducted by the Children’s Hospital of Philadelphia suggests that Project: Evo, the digital medicine developed by Akili Interactive Labs that is delivered via a video game, continually engaged children with autism spectrum disorder (ASD) and reduced their ADHD symptoms, although more objective measures of cognitive control were mixed. Topline data Nineteen children aged...