Digital Therapeutics (DTx) are a high-growth subset of SaMD that deliver evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder. Unlike a general wellness app, a DTx is "prescribed" by a physician and must prove its efficacy through clinical trials. Common applications include Cognitive Behavioral Therapy (CBT) apps for insomnia or depression, and...

The 2025 SaMD market has seen a surge in Digital Therapeutics (DTx) specifically designed for pediatric neurodevelopmental conditions like ADHD and Autism. These SaMDs often take the form of "Therapeutic Video Games" that use sensory-motor tasks to strengthen neural pathways associated with executive function. A landmark 2025 study demonstrated that these digital interventions, when used...