Digital therapeutics

01Overview and value chain

Markers: [EC: MDR 2017/745 | OECD: Biotech-health | Regulator: FDA (USA), EMA (European Union), NMPA (China)]

Digital therapeutics are software-as-medical-device treatments that deliver a regulator-cleared clinical intervention, distinct from general wellness or fitness apps. Akili Interactive received FDA authorization for EndeavorOTC in June 2024, the first FDA clearance of a digital treatment for adult ADHD delivered through a video game, and launched ENDEAVORRIDE in Japan with Shionogi in June 2026 as the first adjunctive therapy app for pediatric ADHD in that market. Big Health received FDA clearance for SleepioRx in August 2024 and for DaylightRx in September 2024, the first FDA-cleared non-drug treatment for generalized anxiety disorder, and raised $23.7 million in February 2026 to scale commercial expansion following new CMS reimbursement codes for digital mental health treatments. Otsuka and Click Therapeutics launched Rejoyn in April 2024, the first-and-only prescription digital therapeutic cleared by the FDA for the adjunctive treatment of major depressive disorder symptoms, and expanded it to Great Britain in June 2025. In Germany, Kaia Health’s digital therapy for musculoskeletal and chronic pain conditions showed sustained impact on pain reduction, functional ability, mental health and cost-effectiveness in a 12-month Rise-uP study, and the company launched a digital pulmonary rehabilitation pilot for COPD patients with MedImprove at ERS 2025 in Amsterdam. In China, ALSOLIFE’s digital therapy intervention for childhood autism spectrum disorder has entered 14 hospitals and 3 rehabilitation institutions in Hainan province, achieving a 94% effective intervention rate under a Hainan government subsidy program, with efficiency reported at three times traditional manual intervention and roughly one-tenth the cost.

The key directions of digital therapeutics are:

1. Prescription digital therapeutics (Prescription Digital Therapeutics): FDA-cleared software delivering a defined clinical intervention as a standalone or adjunctive treatment — Akili Interactive’s EndeavorOTC/ENDEAVORRIDE for ADHD and Otsuka/Click Therapeutics’ Rejoyn for depression.
2. Digital mental health treatment (Digital Mental Health Treatment): non-drug digital treatments for common mental health conditions, now with dedicated reimbursement coding — Big Health’s SleepioRx (insomnia) and DaylightRx (anxiety).
3. Musculoskeletal digital rehabilitation (Musculoskeletal Digital Rehab): app-based digital therapy for chronic pain and respiratory rehabilitation, validated in randomized trials — Kaia Health.
4. Pediatric digital intervention (Pediatric Digital Intervention): standardized digital intervention protocols for pediatric developmental conditions, deployed at scale under government subsidy — ALSOLIFE’s autism intervention in Hainan.

Sectoral value chain

[clinical intervention/software design] ──> [randomized clinical trial validation] ──> [regulatory clearance (FDA/MDR/NMPA)]
                                                    │
                                       (prescription/reimbursement pathway)
                                                    │
                                                    ▼
[market/indication expansion] <─── [real-world outcome data generation] <─────┘

Value chain levels

Cross-cutting technologies of the sector:

• Software-as-medical-device clinical validation (Prescription Digital Therapeutics): randomized trial evidence supporting a specific FDA/MDR/NMPA-cleared clinical claim, distinguishing regulated digital therapeutics from general wellness apps.
• Reimbursement coding infrastructure (Digital Mental Health Treatment): dedicated CMS/insurance billing codes enabling prescription digital therapeutics to be reimbursed like a drug or device.
• Standardized scalable intervention protocols (Pediatric Digital Intervention): digitized clinical protocols that reduce reliance on individually trained therapists, enabling government-subsidized scale-up.

02US

The US hosts the leading concentration of FDA-cleared prescription digital therapeutics, spanning ADHD, insomnia, anxiety and depression with newly established reimbursement pathways.

Akili Interactive, Big Health, Click Therapeutics, FDA

• Akili Interactive: received FDA authorization for EndeavorOTC in June 2024, the first FDA clearance of a digital treatment for adult ADHD delivered through a video game, and launched ENDEAVORRIDE in Japan with Shionogi in June 2026 as the first adjunctive therapy app for pediatric ADHD in that market.
• Big Health: received FDA clearance for SleepioRx in August 2024 and for DaylightRx in September 2024, the first FDA-cleared non-drug treatment for generalized anxiety disorder, and raised $23.7 million in February 2026 to scale commercial expansion following new CMS reimbursement codes for digital mental health treatments.
• Click Therapeutics (with Otsuka): launched Rejoyn in April 2024, the first-and-only prescription digital therapeutic cleared by the FDA for the adjunctive treatment of major depressive disorder symptoms, and expanded it to Great Britain in June 2025.
• FDA framework: digital therapeutics clear FDA via 510(k) or De Novo review per specific clinical claim, with new CMS reimbursement coding for digital mental health treatments a key 2026 development supporting commercial scale-up.

03CN

China’s confirmed digital therapeutics activity centers on Hainan province, which has built a dedicated regulatory fast-track and now hosts 73 digital therapeutics companies with dozens of deployed products.

ALSOLIFE, NMPA

• ALSOLIFE: its digital therapy intervention for childhood autism spectrum disorder has entered 14 hospitals and 3 rehabilitation institutions in Hainan province, achieving a 94% effective intervention rate under a Hainan government subsidy program (approximately 3,000 yuan per patient), with efficiency reported at three times traditional manual intervention and roughly one-tenth the cost.
• Hainan regulatory fast-track: Hainan’s provincial drug regulator has approved 10 digital therapeutic products as Class II medical devices, with average review time of 29 working days — 79% faster than the statutory requirement — and 73 companies have received specialized regulatory guidance under a provincial policy supporting the industry.
• NMPA pathway: digital therapeutics register with NMPA as Class II or Class III medical devices depending on risk classification, with Hainan’s provincial fast-track feeding into the broader national framework.

04EU

Germany anchors Europe’s digital therapeutics capacity through a company focused on musculoskeletal and respiratory chronic disease, validated in randomized trials and expanding into new indications.

Kaia Health, MDR

• Kaia Health (Germany; founded 2016): its digital therapy for musculoskeletal and chronic pain conditions showed sustained impact on pain reduction, functional ability, mental health and cost-effectiveness in a 12-month Rise-uP study, and the company launched a digital pulmonary rehabilitation pilot for COPD patients with MedImprove at ERS 2025 in Amsterdam.
• MDR framework: digital therapeutics sold in the EU require conformity assessment under the Medical Device Regulation (MDR 2017/745) as software medical devices, with Kaia Health’s randomized-trial evidence base supporting its regulatory and reimbursement positioning.

05Leading companies and research institutes

06Tech stack and innovations

The stack applies software-as-medical-device engineering to deliver a regulator-cleared clinical intervention, validated in randomized trials rather than offered as general wellness software.

1. Prescription digital therapeutic delivery (Prescription Digital Therapeutics):
   • Akili Interactive’s video-game-based EndeavorOTC and Otsuka/Click Therapeutics’ Rejoyn app each deliver an FDA-cleared clinical intervention for ADHD and depression respectively.
2. Digital mental health treatment platforms (Digital Mental Health Treatment):
   • Big Health’s SleepioRx and DaylightRx are both FDA-cleared non-drug digital treatments, now supported by dedicated CMS reimbursement coding for digital mental health treatments.
3. Musculoskeletal and respiratory digital rehabilitation (Musculoskeletal Digital Rehab):
   • Kaia Health’s app-based digital therapy is validated in a 12-month randomized Rise-uP study for chronic pain and is expanding into COPD pulmonary rehabilitation.
4. Scalable pediatric digital intervention (Pediatric Digital Intervention):
   • ALSOLIFE’s standardized digital intervention protocol for autism spectrum disorder reduces reliance on individually trained therapists, enabling government-subsidized deployment across multiple institutions.

07Value chains and production pipelines

Industrial pipeline of a digital therapeutic (FDA 510(k)/De Novo / EU MDR 2017/745 / NMPA)

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Clinical intervention/ │ ───> │ 2. Randomized clinical    │
│    software design           │      │    trial validation         │
└───────────────────────────┘      └───────────────────────────┘
                                                   │
                                                   ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Prescription/            │ <─── │ 3. Regulatory clearance  │
│    reimbursement pathway     │      │                           │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Real-world outcome     │ ───> │ 6. Market/indication      │
│    data                      │      │    expansion                │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Clinical intervention and software design

A software intervention targeting a specific clinical indication is designed, as with Akili Interactive’s video-game-based attention-training mechanism versus ALSOLIFE’s standardized autism-intervention protocol.

Stage 2: Randomized clinical trial validation

The software intervention is tested against a control in a randomized trial, the evidence base behind Kaia Health’s 12-month Rise-uP study and the trials supporting Big Health’s SleepioRx and DaylightRx clearances.

Stage 3: Regulatory clearance

The product clears FDA 510(k)/De Novo review, EU MDR conformity assessment, or NMPA Class II/III registration, as with Akili’s EndeavorOTC (first FDA-cleared adult-ADHD video-game treatment) and Hainan’s 10 provincially-approved Class II digital therapeutic products.

Stage 4: Prescription and reimbursement pathway

The cleared product becomes prescribable, supported by reimbursement coding, exemplified by Big Health’s February 2026 funding round explicitly tied to new CMS reimbursement codes for digital mental health treatments.

Stage 5: Real-world outcome data generation

Usage, adherence and clinical outcome data are collected, as with ALSOLIFE’s reported 94% effective intervention rate across 14 hospitals and 3 rehabilitation institutions in Hainan.

Stage 6: Market and indication expansion

Outcome evidence supports geographic or indication expansion, the pattern behind Akili’s Japan launch with Shionogi, Click Therapeutics’ UK expansion of Rejoyn, and Kaia Health’s expansion from musculoskeletal pain into COPD pulmonary rehabilitation.