--- title: "DTx, Digital Therapeutics | MedTech Terms" description: "Software-based interventions that prevent, manage, or treat disease. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Digital Therapeutics [All terms](/terms) Market Segments [Software Lifecycle](/ecosystems/software-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)DTx # Digital Therapeutics Software-based interventions that prevent, manage, or treat disease. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Digital therapeutics deliver evidence-based therapeutic interventions through software - mobile apps, browser-based programs, or VR - to treat conditions including substance-use disorder, insomnia, ADHD, and chronic pain. ## What this means in practice FDA-cleared examples include Pear reSET (now defunct, illustrating reimbursement risk), Akili EndeavorRx (ADHD), and Somryst (insomnia). Reimbursement remains the dominant commercial challenge; CMS PFS [DTx](/terms/samd-dtx) codes ( [HCPCS](/terms/hcpcs)) are emerging. Common pitfalls - • Building a clinically validated product without a confirmed reimbursement path or B2B payer contract. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Wearable Medical Devices Body-worn devices that continuously monitor physiological signals. ](/terms/wearables)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Mentioned in recent activity 2 entries PubMed (2) [A study on the acceptance intention of digital therapeutics based on UTAUT2 and MIR. ](https://pubmed.ncbi.nlm.nih.gov/42052417/) Digital health · 2026-01-01 [Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. ](https://pubmed.ncbi.nlm.nih.gov/42037982/) Digital health · 2026-01-01 ## Latest in MedTech [View all](/latest?term=digital-therapeutics) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-01-01 [A study on the acceptance intention of digital therapeutics based on UTAUT2 and MIR. ](https://pubmed.ncbi.nlm.nih.gov/42052417/) Digital health - PubMed 2026-01-01 [Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. ](https://pubmed.ncbi.nlm.nih.gov/42037982/) Digital health ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 Digital Therapeutics Alliance· 1 MedTech Dive· 1 AdvaMed· 1 1. [1 DTA Verified Digital Therapeutics Alliance · dtxalliance.org ](https://dtxalliance.org/) 2. [2 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) 3. [3 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Acronym DTx Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=digital-therapeutics) Learn in 60 seconds Card Lesson Quiz Software-based interventions that prevent, manage, or treat disease. - · FDA-cleared examples include Pear reSET (now defunct, illustrating reimbursement risk), Akili EndeavorRx (ADHD), and Somryst (insomnia). - · Reimbursement remains the dominant commercial challenge; CMS PFS DTx codes (HCPCS) are emerging. Remember this Watch out: Building a clinically validated product without a confirmed reimbursement path or B2B payer contract. Related terms - [Software as a Medical Device(SaMD) ](/terms/samd) - [Wearable Medical Devices ](/terms/wearables) You may also need Auto-suggested from Market Segments and shared keywords. - [Digital Therapeutic(DTx) ](/terms/samd-dtx) - [Neuromodulation ](/terms/neuromodulation) - [Remote Patient Monitoring(RPM) ](/terms/remote-patient-monitoring) - [Brainjacking ](/terms/brainjacking) - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)