FDA Clears Prescription Digital Therapeutic LumosityRx for Adults with ADHD

The FDA has granted 510(k) clearance to LumosityRx, a prescription digital therapeutic (PDT) designed to improve attention function in adults aged 22 to 55 years with attention-deficit/hyperactivity disorder (ADHD). The mobile-based platform represents a rare FDA-cleared digital therapeutic specifically targeting attention in adults with ADHD and is intended for use as part of a broader therapeutic program, according to manufacturer Lumos Labs.

LumosityRx builds on the technology behind the consumer Lumosity brain-training platform and delivers clinically validated versions of 13 cognitive training games targeting processes that contribute to attention function. The product was evaluated in a large, randomized, double-blind, sham-controlled clinical trial and demonstrated statistically significant improvements on objective and clinician-rated measures of attention, Lumos stated.

“With LumosityRx, we’re taking the core science and technology behind Lumosity and applying it to help people with ADHD, where attention is crucial to everyday life,” Bob Schafer, PhD, neuroscientist and head of Lumos Labs’ digital medicine division, said in a statement.

Clinical Need in Adult ADHD

ADHD persists into adulthood for approximately 15.5 million individuals and is associated with functional impairment in work performance, relationships, and mental well-being.² While pharmacologic and behavioral therapies remain foundational, many adults continue to report unmet needs related to symptom control, tolerability, and integration of treatment into daily life.²

The company states that LumosityRx is intended to complement existing approaches and may be used alongside clinician-directed therapy, medication, and/or educational programs. The company notes that while the therapeutic targets attention, it does not aim to directly treat all behavioral symptoms of ADHD, such as hyperactivity.

“Adult ADHD is often misunderstood, and many patients still struggle to find treatment options that fit into their lives,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Inc, in Las Vegas, NV, and principal investigator of the pivotal trial, said in a statement. “Digital therapeutics like LumosityRx open up new possibilities: clinically validated, highly engaging, and accessible from a mobile device.”

Evidence From the GAMES Study

FDA clearance was supported by results from the GAMES Study, a randomized, double-blind, sham-controlled clinical trial that enrolled more than 500 participants aged 22 to 55 years with a confirmed diagnosis of ADHD, Lumos said. Across 13 US clinical sites, participants were randomly assigned to use LumosityRx or sham game-play therapy for approximately 15 minutes daily for 9 weeks.¹

The primary endpoint analysis showed that improvement in the Test of Variables of Attention (TOVA) Attention Comparison Score (ACS) was statistically significantly larger in the therapeutic arm than in the control arm (P =.015). Researchers observed clinically meaningful gains in attention, defined for the study as improvements greater than 1.4 points on the TOVA, in 44.2% of participants using LumosityRx.¹

Lumos reported that blinded clinician assessments also favored the digital therapeutic. Investigators rated participants using LumosityRx as significantly more improved than controls on the Clinical Global Impression–Improvement (CGI-I) scale (P =.0087), with approximately 1 in 3 participants rated as “much improved” or better.

Participants themselves reported improvements in quality of life, with a "clinically meaningful" increase of 8.7 points on the Adult ADHD Quality of Life (AAQoL) scale among those using LumosityRx. Adherence was high, with 97% of prescribed use completed over the 9-week treatment period, according to the company.

No serious adverse events were reported during the trial, and the rate of treatment-related adverse events was less than 1%. Reported adverse effects were described as mild.

LumosityRx Indication

Lumos explained in its announcement that the FDA cleared the digital therapeutic under the name Prismira, although it will be marketed as LumosityRx. The app is indicated to improve attention function in adults aged 22–55 years with primarily inattentive or combined-type ADHD. Patients who engage with [LumosityRx] demonstrate improvements in a digitally assessed measure of sustained and selective attention, TOVA, and may not display benefits in typical behavioral symptoms, such as hyperactivity.

The product should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs. The labeling states that [LumosityRx] may not be appropriate for users with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device.

With FDA clearance secured, Lumos Labs reports that it is preparing for a nationwide launch and working to support access to the prescription platform. Additional information is available at www.lumosity.com/rx.

References

1. Lumosity announces FDA clearance of LumosityRx, a prescription digital therapeutic for adults with ADHD. News release. Lumos Labs. December 10, 2025. Accessed December 15, 2025. https://www.businesswire.com/news/home/20251210648945/en/Lumosity-Announces-FDA-Clearance-of-LumosityRx-a-Prescription-Digital-Therapeutic-for-Adults-with-ADHD

2. Staley BS, Robinson LR, Claussen AH, et al. Attention-deficit/hyperactivity disorder diagnosis, treatment, and telehealth use in adults—National Center for Health Statistics Rapid Surveys System, United States, October–November 2023. MMWR Morb Mortal Wkly Rep. 2024;73:890–895. doi:10.15585/mmwr.mm7340a1