Top 10 FDA-Authorized Digital Therapeutics in 2025

Digital therapeutics (DTx) represent a breakthrough in modern medicine by using clinically validated software to deliver evidence-based therapies for various medical and mental health conditions. As of 2025, the FDA has authorized several cutting-edge digital therapeutics that are transforming how patients receive treatment and how clinicians manage care. Below is our curated list of the 10 most impactful FDA-approved digital therapeutics shaping the industry today.

Why This Matters

Digital therapeutics (DTx) have moved from curiosity to clinical reality. In the United States, the Food and Drug Administration (FDA) now regulates a growing roster of software‑based medical treatments delivered through mobile apps, connected sensors, wearables, or immersive technologies. These products are prescribed by clinicians, supported by clinical evidence, and commonly used alongside standard care such as medication, psychotherapy, rehabilitation, or medical devices.

How We Ranked the Top 10

This ranking is based on a combination of clinical impact, regulatory milestones, and market influence. We prioritized digital therapeutics with strong FDA validation, proven clinical outcomes, and innovative delivery methods such as VR, game-based therapy, or wearable tech. Market adoption and partnerships with major healthcare players also influenced the list, as these factors indicate real-world success. Finally, newer and high-profile approvals were ranked higher to reflect current industry momentum. Our goal is to highlight digital therapeutics that are both groundbreaking and shaping the future of patient care.
Below is our curated list of the 10 most impactful FDA-approved digital therapeutics shaping the industry today.

Quick Snapshot – The 2025 Leaders

1. Rejoyn

Company: Otsuka & Click Therapeutics

FDA Authorized: 2024

Indication: Adjunctive treatment of Major Depressive Disorder (MDD) in adults.

Access: Prescription (Rx-only).

Modality: Mobile CBT and emotional regulation exercises.

Details: Rejoyn is designed as an adjunct to antidepressant therapy and provides daily interactive exercises that help patients track and improve their mood. Built with the latest advances in cognitive behavioral therapy (CBT), it personalizes sessions based on user progress and has demonstrated significant improvements in depressive symptoms during clinical trials. It stands out for its seamless integration into clinicians’ workflows and its potential to improve treatment adherence.

2. EndeavorRx

Company: Akili Interactive

FDA Authorized: 2020

Indication: Attention-Deficit/Hyperactivity Disorder (ADHD) in children 8–12 years old.

Access: Prescription (Rx-only).

Modality: Adaptive video game therapy.

Details: EndeavorRx is the world’s first FDA-cleared prescription video game. It is scientifically engineered to improve attention function by targeting specific neural systems through a series of game-based challenges. Clinical studies have shown measurable improvements in focus and sustained attention, making it a popular adjunct to conventional ADHD treatments. The program is supported by a robust patient engagement dashboard for clinicians and parents.

3. Somryst

Company: Pear Therapeutics (Somryst acquired by Nox Health Group)

FDA Authorized: 2020

Indication: Chronic insomnia in adults.

Access: Prescription digital therapeutic.

Modality: 9-week CBT-I program.

Details: Somryst delivers a structured, 9-week cognitive behavioral therapy for insomnia (CBT-I) protocol via mobile devices. It has been clinically validated to improve sleep quality, reduce sleep onset latency, and address maladaptive sleep habits. The therapy is guided by interactive modules that simulate a personalized sleep coach, allowing patients to implement behavioral changes at their own pace.

4. reSET

Company: Pear Therapeutics (reSET acquired by Harvest Bio)

FDA Authorized: 2017

Indication: Substance Use Disorder (non-opioid).

Access: Prescription digital therapeutic.

Modality: CBT + contingency management.

Details: reSET is designed to treat Substance Use Disorder by delivering a 12-week interactive program built around CBT principles. It provides skills training, relapse prevention strategies, and motivational reinforcement through contingency management. Clinical trials demonstrated significant increases in treatment adherence and abstinence rates when used alongside outpatient therapy.

5. reSET-O

Company: Pear Therapeutics (reSET-O acquired by Harvest Bio)

FDA Authorized: 2018

Indication: Opioid Use Disorder.

Access: Prescription digital therapeutic.

Modality: 12-week CBT-based program.

Details: reSET-O is tailored for patients receiving medication-assisted treatment for opioid use disorder. It complements pharmacotherapy by teaching coping skills, managing triggers, and tracking progress. Its evidence-based program has been recognized for reducing opioid relapse rates and improving patient outcomes when integrated into structured treatment programs.

6. RelieVRx

Company: AppliedVR

FDA Authorized: 2021

Indication: Chronic lower back pain.

Access: Prescription device.

Modality: Immersive VR therapy.

Details: RelieVRx uses immersive virtual reality to help patients manage chronic pain by combining distraction therapy with cognitive behavioral pain management techniques. It offers a non-pharmacological solution, making it ideal for patients seeking alternatives to opioids. Its clinical validation shows meaningful pain reduction and improved quality of life outcomes.

7. NightWare

Company: NightWare, Inc.

FDA Authorized: 2020

Indication: PTSD-related nightmares.

Access: Prescription device.

Modality: Apple Watch-based intervention.

Details: NightWare uses biometric data collected via an Apple Watch to detect nightmare events and gently intervene through haptic feedback, disrupting nightmares without waking the user fully. It is particularly beneficial for military veterans and trauma survivors suffering from severe sleep disturbances.

8. BlueStar

Company: Welldoc

FDA Authorized: 2010

Indication: Diabetes management.

Access: Prescription/payer programs.

Modality: Data-driven digital coaching.

Details: BlueStar is a clinically validated mobile app that helps diabetes patients track blood glucose, manage diet, and receive personalized coaching. It integrates with various devices and EMRs, providing real-time data insights for both patients and healthcare providers.

9. Mahana IBS

Company: Mahana Therapeutics

FDA Authorized: 2022

Indication: Irritable Bowel Syndrome.

Access: Prescription digital therapeutic.

Modality: CBT-based therapy.

Details: Mahana IBS leverages cognitive behavioral therapy techniques to help patients manage the pain and discomfort of irritable bowel syndrome. Its digital modules teach stress management, gut-focused relaxation, and coping strategies, helping reduce symptom severity and improve daily quality of life.

10. Propeller

Company: Propeller Health

FDA Authorized: 2012

Indication: Asthma and COPD adherence.

Access: Prescription/payer programs.

Modality: Connected inhaler sensors.

Details: Propeller pairs Bluetooth-enabled inhaler sensors with a mobile app to track inhaler use and provide personalized feedback. It helps patients stay adherent to treatment plans, while providing clinicians with actionable data for optimizing respiratory care.

Final Take

The FDA’s expanding roster of authorized digital therapeutics shows that clinically validated software is becoming core care infrastructure. apart from these Top 10 FDA‑Authorized Digital Therapeutics in 2025, others from VR pain therapy to app‑based addiction treatment and connected inhaler sensors, these products extend reach, personalize care, and generate actionable data that can reshape reimbursement and population health strategy.

Stay current. Build smarter. Lead the future of digital medicine at DTxHub.com.