Wearable Biotech & Digital Biomarkers
EndeavorRx Prescription Digital Therapeutic
by Akili Interactive Labs, Inc.
The first FDA-authorized prescription video game that treats pediatric ADHD cognitive symptoms
Category
Wearable Biotech & Digital Biomarkers
Founded
2011
Headquarters
Boston, MA, USA
Overview
Akili Interactive developed EndeavorRx, the first prescription digital therapeutic (PDT) to receive FDA marketing authorization for treatment of a medical condition. EndeavorRx is a video game-based intervention designed for children ages 8–12 with primarily inattentive or combined-presentation ADHD. The game delivers precisely calibrated sensory stimuli and simultaneous motor demands, algorithmically adjusting challenge level to train the prefrontal cortical networks that underlie attentional control and working memory. Clinicians prescribe EndeavorRx through the Akili prescription portal, and the game is accessed via iOS or Android. Pediatric neurologists, psychiatrists, and primary care physicians prescribe EndeavorRx as part of a multimodal ADHD treatment program, which may include behavioral therapy and/or medication. The therapy is particularly relevant for families seeking non-pharmacological treatment options or adjunctive treatment to supplement existing ADHD management. Multiple randomized controlled trials demonstrated statistically significant improvements in objective attentional performance measures in children using EndeavorRx. Akili went public via SPAC in 2022 and subsequently shifted its commercial strategy, licensing the EndeavorRx technology to Endeavor Health while pursuing platform partnerships with pharmaceutical companies and health systems to embed cognitive assessment and therapeutic tools into existing care pathways. The company's broader technology platform — Selective Stimulus Management Engine (SSME) — generates patent-protected digital medicine intellectual property applicable across multiple cognitive conditions including depression and multiple sclerosis.
Key Features
Digital Endpoint Validation
Validate digital biomarker endpoints for use in decentralized clinical trials.
Longitudinal Health Tracking
Capture disease progression patterns invisible to periodic clinic visits with continuous data.
EHR Integration
Seamless integration with electronic health records for clinical data enrichment.
Patient Engagement Platform
Improve treatment adherence through real-time feedback, alerts, and coaching via mobile apps.
Multi-Sensor Fusion
Combine data from accelerometer, PPG, temperature, and biochemical sensors for comprehensive profiles.
Pros & Cons
Pros
- +Non-invasive biosensors measure glucose, lactate, cortisol, and other analytes through skin contact
- +Digital biomarker endpoints enable decentralized clinical trials with remote patient monitoring
- +Longitudinal data collection captures disease progression patterns invisible to periodic clinic visits
- +Integration with electronic health records enables seamless clinical data enrichment
- +Patient engagement features improve treatment adherence through real-time feedback and alerts
- +Continuous physiological monitoring captures real-time biomarker data outside clinical settings
- +AI algorithms detect early disease signals from wearable sensor data with clinical-grade accuracy
Cons
- −Patient compliance with continuous wearable device use can be challenging in clinical trials
- −Data privacy and security concerns with continuous health monitoring raise ethical questions
- −Battery life and device comfort limitations affect long-term monitoring capabilities
- −Sensor accuracy and reliability vary significantly across different physiological measurements
Use Cases
Research Workflow Optimization
AI-powered optimization of research workflows to accelerate discovery timelines and improve reproducibility.
Data Analysis & Insights
Machine learning analysis of complex biological datasets to extract actionable insights and identify patterns.
Collaboration & Knowledge Management
Platform-enabled collaboration across distributed research teams with integrated data sharing and knowledge capture.