When you think of medicine, you probably picture a pill or an injection. But FDA digital therapeutics, software-based treatments approved by the U.S. Food and Drug Administration to prevent, manage, or treat medical conditions. Also known as digital medicine, they’re apps or programs that deliver clinical interventions directly through smartphones, tablets, or computers. These aren’t wellness trackers or meditation apps—they’re medical devices. The FDA clears them the same way it approves drugs: with clinical data proving they work. And they’re not just for mental health. They’re being used to treat chronic pain, ADHD, substance use disorders, and even diabetes.
What makes them different from regular apps? Therapeutic software, a type of digital therapeutic that delivers structured, evidence-based behavioral or cognitive interventions must meet strict standards. It can’t just suggest you drink more water—it has to show, through trials, that it reduces HbA1c levels in diabetics. FDA approval, the official clearance process that ensures a digital therapeutic is safe and effective for its intended use means the product has been tested on real patients, not just lab simulations. You’ll find these in use alongside traditional meds—for example, a patient taking opioids for chronic pain might also use a digital program that teaches pain-coping skills, reducing their reliance on pills.
These tools aren’t magic. They work because they change behavior. A program for ADHD might use gamified tasks to train attention. A substance abuse app might send daily check-ins and coping strategies when cravings hit. And because they’re digital, they can adapt in real time. If a user skips three days of sessions, the system might adjust the difficulty or send a reminder. That’s something a pill can’t do.
But they’re not for everyone. They require some tech comfort, consistent use, and often a doctor’s prescription. And while they’re growing fast, the FDA has only approved about 50 so far. Still, the trend is clear: medicine is moving beyond the bottle. If you’re managing a long-term condition, a digital therapeutic might be an option worth asking your doctor about—especially if you’ve tried other treatments without success.
Below, you’ll find real-world examples of how digital therapeutics fit into broader medication safety, drug interactions, and patient care. From how they’re regulated to how they interact with other treatments, these posts show you what’s actually working on the ground—not just what’s being marketed.
Digital therapeutics are now FDA-cleared medicines that improve medication adherence and outcomes. Learn how they interact with drugs, their real risks, who benefits most, and what to ask your doctor in 2025.