Overview
Lumos Labs has received FDA 510(k) clearance for LumosityRx, a prescription digital therapeutic (PDT) designed to improve attention in adults aged 22 to 55 with ADHD.
Built on Lumosity’s cognitive training platform, LumosityRx offers a clinically validated, mobile-based treatment that can be used alongside clinician-directed therapy, medication or educational programs.
The News
The FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic featuring 13 clinically validated cognitive training games that target attention-related cognitive processes in adults with ADHD. The clearance is supported by the GAMES Study, a randomized, double-blind, sham-controlled trial involving more than 500 participants across 13 U.S. clinical sites.
Patients using LumosityRx demonstrated significantly greater improvements in sustained and selective attention than the control group, with statistically significant gains on the TOVA Attention Comparison Score (p=0.0149) and superior clinician-assessed improvement on the CGI-I scale (p=0.0087). Additionally, 44.2% of participants achieved clinically meaningful attention improvements, while users reported an 8.7-point improvement in quality of life. The program achieved a 97% treatment completion rate over nine weeks, with no serious adverse events and treatment-related adverse effects reported in less than 1% of participants.
Lumos Labs is now preparing for a nationwide commercial launch of LumosityRx.
Industry Perspective
Prescription digital therapeutics are expanding treatment options for neurological and behavioral disorders by providing clinically validated, software-based interventions that complement traditional care. FDA-cleared digital therapies are increasingly supported by robust clinical evidence and offer scalable, accessible treatment alternatives.
Strategic Impact
The FDA clearance marks Lumos Labs’ transition from consumer brain training to regulated digital medicine. By combining its neuroscience expertise with clinically validated software, the company expands its presence in digital therapeutics while offering adults with ADHD a new evidence-based treatment option that can be integrated into routine clinical care.
Source: Lumosity
