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 alongside traditional pharmacotherapy, led to a 40% improvement in focus scores compared to medication alone.

These products are regulated as "Class II" medical devices, requiring prospective, randomized controlled trials. Data on the reimbursement pathways for these "Prescription Digital Therapeutics" (PDTs) and their integration into school-based health programs can be found in the Software as a Medical Device Market resource. By gamifying the treatment process, these SaMDs address the critical issue of "Pediatric Adherence," turning a chore into an engaging activity.