EndeavorRx™

Primary DI
00850002639018
Brand
EndeavorRx™
Company
AKILI INTERACTIVE LABS, INC.
Model
Treatment 1
Catalog number
50002063901
Device description
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. The EndeavorRx program is software-as-medical device (SaMD) that resides on the user’s mobile device and can be executed at home. EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili’s proprietary, patented, technology platform which is designed for the selective targeting and modulation of specific cognitive neural systems in the brain related to attention function. EndeavorRx uses Akili’s adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver the presentation of stimuli that are designed to engage targeted neural systems which play a key role in attention function. In a closed-loop system, the adaptive SSME algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient. EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance.
Published
2020-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFTDigital Therapeutic Software For Attention Deficit Hyperactivity DisorderObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200026000EndeavorRxAkili Interactive Labs, Inc.2020-06-15QFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002639018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002639018008500026390188500026390180850002639018

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive therapy softwareA software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading, stimulating game-like activities); it is not intended for kinesiology-based neuromuscular rehabilitation. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used at home, school, and in clinical settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617-456-0984skellogg@akiliinteractive.com
1-844-254-5447info@akiliinteractive.com

Regulatory Flags#

DUNS number
078413778
Device count
1
Lot or batch
true
Manufacturing date on label
true