When you think of medicine, you probably picture pills, injections, or surgery. But now, the FDA digital therapeutics, prescription-grade software programs cleared by the U.S. Food and Drug Administration to treat, manage, or prevent medical conditions. Also known as DTx, these are not wellness apps—they’re regulated medical devices that require a doctor’s prescription and have clinical proof behind them. Unlike fitness trackers or meditation apps, FDA digital therapeutics are held to the same standards as drugs. They’re tested in real clinical trials, monitored for safety, and designed to change patient behavior or biological outcomes—like reducing panic attacks, improving diabetes control, or helping kids with ADHD focus better.
These tools often work by using cognitive behavioral therapy (CBT), biofeedback, or gamified learning to rewire how the brain responds to pain, stress, or cravings. For example, one FDA-approved program helps patients with chronic lower back pain by guiding them through daily exercises and thought patterns that reduce fear of movement. Another helps teens with ADHD by training attention through interactive tasks during 25-minute sessions, five days a week. These aren’t supplements. They’re not optional. They’re prescribed like insulin or blood pressure meds—and they’re meant to be used consistently over weeks or months.
What makes them different from regular apps? The FDA doesn’t clear apps that just remind you to take your pills. It approves software that actually changes outcomes. Take reSET, a prescription app for substance use disorder that delivers CBT and tracks relapse triggers. It’s been shown in trials to double abstinence rates compared to counseling alone. Or EndeavorRx, a video game approved for children with ADHD that improves attention by targeting neural pathways through sensory-motor challenges. These aren’t gimmicks. They’re built on neuroscience and validated by data.
And they’re growing fast. The FDA has approved over 30 digital therapeutics since 2017, mostly for mental health, chronic pain, diabetes, and neurological conditions. But they’re not magic. They need to be used correctly. A patient might get prescribed a digital therapy for anxiety, but if they skip sessions or don’t pair it with therapy, it won’t work. That’s why doctors who prescribe these tools also train patients on how to use them—just like explaining how to take a new antibiotic.
You won’t find these apps on the App Store. You need a prescription, and they’re often delivered through secure portals or paired with wearable sensors. Some are covered by insurance, others aren’t. But they’re part of a bigger shift: medicine is no longer just about what you swallow—it’s about what you do, how often, and how consistently. The future of treatment isn’t just pills. It’s behavior, data, and software working together. Below, you’ll find real-world examples of how these tools are being used, what they’ve been proven to do, and what you need to know before asking your doctor about them.
