FDA clears Lumosity brain training games as a prescription app for adult ADHD

 ADHD in the News 2025-12-11


Lumos Labs has obtained a clearance from the FDA for its popular Lumosity brain training platform, greenlighting a version of it to be marketed as a prescription digital therapeutic for adults with attention-deficit/hyperactivity disorder (ADHD) for the first time. Dubbed LumosityRx, the agency's 510(k) covers the smartphone app's use in improving attention among people between the ages of 22 and 55. According to Lumos, more than 100 million people have already used its Lumosity platform, and the FDA's clearance marks the company's expansion from consumer software to clinical-grade approaches.