A video game has been FDA-cleared as a prescription treatment for pediatric ADHD. Its name is EndeavorRx. Most patients have never heard of it. Digital therapeutics sit at an unusual intersection: software products, typically smartphone apps, that have been through clinical trials and regulatory clearance to treat specific medical conditions. The category has matured significantly. The business model around it has not.
What separates DTx from wellness apps
A wellness app makes general claims about feeling better. A digital therapeutic claims to treat a specific medical condition, has clinical evidence backing that claim, and in many cases carries regulatory clearance allowing such claims. The line matters legally and clinically.
Conditions DTx have cleared for
- Insomnia. Somryst (CBT-I delivered digitally) was an early FDA clearance.
- Substance use disorders. reSET and reSET-O target alcohol/substance use and opioid use disorder respectively.
- ADHD. EndeavorRx — the video game — for pediatric ADHD.
- Type 2 diabetes. Several DTx target behavior change for glycemic control.
- Anxiety and depression. Several cleared products in Europe; the US picture is more fragmented.
- Chronic pain. A handful of cleared products for chronic lower back pain and adjacent conditions.
Why you probably have not encountered one
The hurdle is not science. It is reimbursement. The category is hard to fit into existing healthcare payment systems. Some DTx companies have struggled financially despite credible evidence behind their products. Pear Therapeutics — which made reSET and Somryst — declared bankruptcy in 2023 despite FDA-cleared products and meaningful clinical adoption.
The international picture is different
Germany’s DiGA system created a path for digital therapeutics to be reimbursed through public insurance after a structured review process. Several other European countries have followed. The US lacks a comparable framework.
What the evidence looks like
Like drug trials, DTx clinical trials are inconsistent in quality. The best products have multiple RCTs against active comparators. The weaker ones have small studies against waitlist controls. The category’s evidence base is improving — but you should read the trials before treating any single DTx as a serious treatment.
How a DTx differs from a regular app
Mechanism
DTx products generally deliver an evidence-based intervention — CBT, mindfulness-based therapy, structured behavior change — as part of a defined treatment program. They typically do not market on engagement metrics.
Use case
Often prescribed by a clinician for a specific condition, with clinician oversight. Some have entirely consumer-facing distribution.
Privacy
DTx products that meet HIPAA standards in the US are more protected than general wellness apps. This matters for therapy-related data.
The patient perspective
If your clinician offers you a DTx as part of a treatment plan, it is reasonable to try one — particularly when access to in-person specialists is limited. Ask four questions:
- What is the underlying evidence?
- What data will be collected, and who has access?
- What happens if it does not work?
- How long is the program?
If you are considering a non-prescription DTx on your own, add a fifth: am I confident this product is actually FDA-cleared or CE-marked, or is it just marketing itself as therapeutic?
Where the category is heading
Despite Pear’s bankruptcy, the DTx category is not dead. Akili (which makes EndeavorRx) and Cognoa (autism-related DTx) continue operating. New companies are entering with conditions like Parkinson’s and post-stroke recovery. The interesting growth area is AI-enabled DTx, where personalization rather than fixed content is the differentiator.
Bottom line
Digital therapeutics are real medicine in software form, with proper clinical trials and regulatory clearance — though the business model around them is still finding its footing. If you are prescribed one, take it as seriously as you would a drug. Ask the same questions. Expect the same kind of evidence base. If you are shopping for one on your own, distinguish carefully between cleared therapeutics and the marketing-led app market.
