FDA-Cleared DTx Verification Tool
Verify Digital Therapeutics Legitimacy
Enter a digital therapeutic name or condition to check FDA clearance status
FDA-cleared digital therapeutics (DTx) are medical treatments, not wellness apps. They require clinical evidence and regulatory review to be prescribed alongside medications. Always check for a 510(k) or De Novo clearance number before use.
Only FDA-cleared DTx can be covered by insurance and provide meaningful medication interaction support. Wellness apps lack medical oversight and may not work with your treatment plan.
By 2025, digital therapeutics are no longer science fiction. They’re in patients’ pockets, tied to their insulin pumps, and quietly working alongside their prescriptions to keep them alive. But here’s the problem most people don’t talk about: when software becomes medicine, it doesn’t just add a feature-it changes how drugs work in your body.
What Exactly Are Digital Therapeutics?
Digital therapeutics, or DTx, are apps and software cleared by the FDA as actual medical treatments. Not wellness trackers. Not step counters. Real medicine. Think of them like a pill you download instead of pick up at the pharmacy.
The first FDA-cleared DTx was reSET in 2018 for opioid addiction. Since then, the list has grown. In September 2024, DaylightRx became the first DTx approved specifically for generalized anxiety disorder. It’s a 90-day cognitive behavioral therapy program delivered through an app. No pills. No doctor visits. Just structured sessions that rewire thought patterns.
These aren’t just for mental health. DarioEngage helps people with diabetes adjust insulin doses based on blood sugar trends. EndeavorRx is a video game approved to treat ADHD in kids. Medisafe reminds patients to take their meds-and tracks whether they actually do. And it works. Studies show DTx can boost medication adherence by up to 25% in chronic conditions where people normally skip doses half the time.
How DTx Changes How Medications Work
Most people think of drug interactions as two pills clashing in the stomach. But with DTx, the interaction happens in your behavior.
Take warfarin, a blood thinner. Missing one dose can lead to a stroke. Taking too much can cause internal bleeding. Traditional systems rely on monthly blood tests and patient memory. DTx platforms like Medisafe track when you scan your pill bottle. If you skip a dose, the app doesn’t just send a reminder. It asks why. Did you run out? Are you scared of bruising? Is it too expensive? Then it connects you to financial aid, explains side effects, or even alerts your pharmacist to refill.
That’s not just adherence. That’s active intervention. And it changes how the drug performs. In a 6-month trial, patients using DarioEngage with their insulin saw a 1.2% greater drop in HbA1c than those on medication alone. That’s not a small number. It’s the difference between prediabetes and full control.
Even more surprising: some DTx can reduce the need for medication. In a study of opioid use disorder, patients using a DTx alongside buprenorphine had 16.3% fewer positive drug tests than those on the drug alone. The software didn’t replace the medication-it made it work better.
The Hidden Risks: When Software Causes Side Effects
Medications have side effects. So do DTx. But we don’t talk about them the same way.
EndeavorRx, the ADHD video game, caused headaches, dizziness, nausea, and even irritability in 7% of users during trials-twice the rate of the control group. These weren’t dangerous, but they were real. And they happened because the game was too intense, too fast, or too frustrating for some kids.
For mental health DTx like DaylightRx, users on Reddit and patient forums report something more subtle: the therapy feels generic. One user said, “It didn’t address my anxiety from my antidepressant side effects.” That’s a problem. If a DTx can’t adapt to your medication’s impact on your mood, it’s not just useless-it could make you feel more isolated.
And then there’s data. DTx collect your location, sleep patterns, heart rate, medication times, even voice tone. SAMHSA warns that mental health DTx have some of the weakest security protocols in digital health. If your anxiety app gets hacked, someone could learn when you take your SSRI, when you skip it, and how you feel afterward. That’s not just a privacy issue. It’s a safety risk.
Who Struggles the Most With DTx?
DTx isn’t for everyone. And that’s not a bug-it’s a design flaw many companies ignore.
Patients over 65 have a 45% higher chance of quitting DTx within the first month if they don’t get hands-on help. One study found 38% of people over 70 gave up within 30 days without a tech navigator. They didn’t understand the app. They couldn’t get past the login screen. They were scared of breaking something.
Even when they stick with it, integration is a nightmare. Many DTx can’t talk to your pharmacy’s refill system. You get a reminder to take your pill, but the app can’t tell your pharmacy you need a refill. You end up running out-and the app blames you for non-adherence.
Providers are frustrated too. Sixty-seven percent say reimbursement is unclear. If you prescribe DaylightRx, will insurance pay for it? How much? Do you need to document it in the EHR? Most clinics don’t know. And without reimbursement, doctors won’t prescribe it.
What’s Changing in 2025?
The FDA is finally catching up. In Q2 2025, they plan to release new guidelines specifically for DTx used with medications. That means more studies will be required to prove how software and pills work together-not just separately.
Pharmaceutical companies are betting big. Seventy-eight percent of the top 20 drug makers now include DTx in their product lines. Why? Because specialty drugs cost $100,000 a year. If patients don’t take them, the company loses money. DTx cuts that risk.
By 2027, Medisafe predicts 65% of specialty prescriptions will require a digital companion just to get covered by insurance. That’s not optional anymore. It’s part of the treatment plan.
And the data is getting smarter. DTx are starting to connect to wearables. Your glucose monitor, your smartwatch, your inhaler-all feeding into one system that tells your doctor, “Your patient’s insulin dose needs to go up because their sleep quality dropped and their stress levels spiked.” That’s not just adherence. That’s precision medicine.
What Should You Do?
If you’re on chronic medication-diabetes, mental health, heart disease, COPD-ask your doctor: “Is there a DTx that works with my treatment?” Don’t assume it’s too new or too complicated. Ask for the name. Ask for proof it’s FDA-cleared. Look up the clinical studies. Don’t trust a wellness app labeled “for anxiety.” Only trust ones with a 510(k) or De Novo clearance number.
If you’re over 65 or not tech-savvy, ask for a digital health navigator. Many clinics now have staff whose only job is to help patients set up and troubleshoot DTx. They’ll walk you through it. They’ll call the pharmacy. They’ll make sure the app talks to your EHR.
If you’re a caregiver or provider, don’t just hand someone an app and say, “Download this.” Schedule a 45-minute onboarding session. Watch them use it. Ask what confuses them. Fix the gaps. DTx only works if it’s part of a human system-not a digital afterthought.
The future of medication isn’t just pills. It’s software that knows when you’re struggling, before you even say it. But that future only works if we treat DTx like medicine-not just another app.
Are digital therapeutics covered by insurance?
Some are, but not all. FDA-cleared prescription DTx like DaylightRx and DarioEngage are increasingly covered by Medicare, Medicaid, and private insurers-especially for chronic conditions like diabetes and mental health. However, coverage varies by state, plan, and provider. Many insurers require prior authorization and proof of clinical need. Non-prescription wellness apps are never covered.
Can digital therapeutics replace my medication?
Rarely. Most DTx are designed as adjuncts-not replacements. DaylightRx treats anxiety with CBT, but it’s not meant to stop your SSRIs. EndeavorRx helps with ADHD symptoms, but stimulants are still the first-line treatment. The goal is to make your medication more effective, not eliminate it. Always consult your doctor before changing any drug regimen.
Do digital therapeutics have side effects?
Yes. While they don’t cause chemical side effects like nausea or drowsiness, DTx can cause emotional or physical stress. Users of EndeavorRx reported headaches, dizziness, frustration, and irritability. Mental health apps have triggered anxiety in some users due to overwhelming content or poor personalization. These are real side effects-and they’re documented in FDA clearance studies.
How do I know if a digital therapeutic is legitimate?
Look for FDA clearance. Search the FDA’s database for the product name and check if it has a 510(k) or De Novo number. Legitimate DTx will list clinical trial results, target conditions, and instructions for use. Avoid apps labeled as “wellness,” “mental health support,” or “anxiety relief” without FDA clearance-they’re not medical devices.
Can digital therapeutics interact with my other medications?
Not chemically-but they can affect how well your medications work. If a DTx improves your adherence to warfarin, your INR levels will stabilize. If it helps you manage stress, you might need less benzodiazepine. Conversely, if the app causes sleep disruption or anxiety, it could worsen side effects from psychiatric meds. Always tell your doctor what DTx you’re using so they can interpret your lab results and adjust doses accordingly.
Why do some patients stop using digital therapeutics?
The top reasons: poor user experience, lack of personalization, technical glitches, no integration with pharmacy systems, and no human support. Elderly patients quit because they can’t figure out the app. Others stop because the content feels robotic or doesn’t address their real concerns-like medication costs or side effects. Without ongoing support, even the best DTx fails.
Is my data safe in a digital therapeutic app?
It depends. FDA-cleared DTx must follow HIPAA and have strong encryption. But many apps, especially those marketed as wellness tools, don’t. A 2023 SAMHSA report found that mental health DTx had the weakest data protections. Always check the privacy policy. Look for whether data is stored on U.S.-based servers, whether it’s shared with third parties, and whether you can delete your data. Never use an app that doesn’t give you clear answers.
Kurt Russell
December 7 2025This is the future, and it’s already here. I’ve seen patients with Type 2 diabetes go from HbA1c 9.8 to 6.1 in four months using DarioEngage-no new meds, just better habits tracked and coached in real time. The app doesn’t just remind them to take insulin-it tells them why skipping it today means a hospital visit next week. That’s not tech. That’s compassion coded into algorithms.
Oliver Damon
December 7 2025The real paradigm shift isn’t the software-it’s the redefinition of adherence. We used to measure compliance by pill counts and clinic visits. Now we’re measuring behavioral fidelity: sleep consistency, stress response, medication scanning patterns. DTx turns passive patients into active participants in their own physiology. But we’re still treating this like a feature, not a clinical modality. We need outcome-based reimbursement models, not fee-for-service inertia.
Stacy here
December 7 2025Let me tell you something they don’t want you to know: every single one of these apps is selling your data to pharma giants. Your anxiety patterns? Your insulin timing? Your voice stress during CBT sessions? That’s not for your care-it’s for predictive modeling so they can upsell you the next $120K/year drug. HIPAA? Please. The FDA clears the app, but the data goes straight to the marketing department. You’re not a patient-you’re a dataset.