Lumosity Announces FDA Clearance of LumosityRx, a Prescription Digital Therapeutic for Adults with ADHD

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SAN FRANCISCO--(BUSINESS WIRE)--Dec 10, 2025--

Lumos Labs, creators of the popular Lumosity brain training platform with over 100 million users, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for LumosityRx, a prescription digital therapeutic (PDT) designed to improve attention in adults with Attention Deficit Hyperactivity Disorder (ADHD), ages 22 to 55.

“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,” said Dr. Bob Schafer, neuroscientist and head of Lumos Labs’ digital medicine division.

A Clinically Validated Option for Adult ADHD

ADHD persists into adulthood for millions, impacting careers, relationships, and mental well-being. LumosityRx provides a new, engaging, and evidence-based alternative for improving attention function. LumosityRx is used as part of a therapeutic program that may include clinician directed therapy, medication, and/or educational programs, which further address symptoms of the disorder, such as hyperactivity.

LumosityRx is a new mobile app that delivers clinically validated versions of 13 Lumosity cognitive training games targeting cognitive processes that contribute to attention function.

“Adult ADHD is often misunderstood, and many patients still struggle to find treatment options that fit into their lives,” said Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine, Inc., and Principal Investigator of the pivotal clinical trial. “Digital therapeutics like LumosityRx open up new possibilities: clinically validated, highly engaging, and accessible from a mobile device.”

Strong Evidence from a Rigorous Clinical Trial

LumosityRx was evaluated in the GAMES Study, a randomized, double-blind, sham-controlled clinical trial that included more than 500 participants across 13 U.S. clinical sites. Participants using LumosityRx showed significantly greater improvement on an objective measure of sustained and selective attention (the TOVA test) compared to those using a control app. Results of the primary endpoint analysis showed that the improvement in the TOVA Attention Comparison Score (ACS) with use of the therapeutic module of the app was statistically significantly larger than in the control arm (p=0.0149).

Clinicians who evaluated participants without knowing which treatment they received rated LumosityRx subjects as significantly more improved than control subjects on a global measure of clinical improvement (the CGI-I), and about one in three were rated as “much improved” or better. Participants also reported meaningful gains in quality of life, and the program had exceptionally high adherence, with 97% of prescribed use completed over the 9-week treatment period. No serious side effects were reported, and the rate of treatment-related adverse events was less than 1%.

• Statistically significant improvement in attention on the TOVA vs. control (p=0.0149)
• 44.2% of participants using LumosityRx showed clinically meaningful gains in attention (improvements of greater than 1.4 points on the TOVA)
• Superior clinician-assessed improvement in global ADHD status on the CGI-I scale vs. control (p=0.0087)
• Clinically meaningful quality of life gains (increase of 8.7 points on AAQoL among participants using LumosityRx)
• 97% completion of prescribed treatment program over a 9-week program, showcasing exceptional treatment compliance
• No serious adverse events; less than 1% rate of mild treatment-related adverse effects

A Natural Evolution in Digital Brain Health

Founded in 2005, Lumos Labs has built a global reputation for combining neuroscience and engaging game design. With over 130 peer-reviewed publications and research collaborations through its Human Cognition Project, Lumos Labs has laid a strong foundation for clinical translation.

The clearance of LumosityRx reflects the company’s expansion from consumer brain training to clinical-grade therapeutics—offering scalable, personalized tools to address unmet needs in brain and cognitive health.

Path to Access and Availability

Lumos Labs is committed to ensuring broad access to LumosityRx for adults with ADHD. With the new FDA clearance, the company is now working toward a product launch that supports seamless access nationwide.

For more information, please visit www.lumosity.com/rx

Indications for Use

This digital therapeutic was cleared by the FDA under the name Prismira, but will be made available as LumosityRx.

Prismira is a digital therapeutic indicated to improve attention function in adults ages 22‐55 years old with primarily inattentive or combined‐type Attention Deficit and Hyperactivity Disorder (ADHD). Patients who engage with Prismira demonstrate improvements in a digitally assessed measure of sustained and selective attention, Test of Variables of Attention (TOVA), and may not display benefits in typical behavioral symptoms, such as hyperactivity. Prismira should be considered for use as part of a therapeutic program that may include clinician directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

Limitations: Prismira may not be appropriate for users with photo‐sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device.

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SOURCE: Lumos Labs

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