Lumos Labs has received FDA 510(k) approval for LumosityRx, a prescription version of its well-known Lumosity brain training platform. As reported by Fierce BioTech, The app is now authorized for adults aged 22 to 55 with attention-deficit/hyperactivity disorder (ADHD), marking the company’s first move into clinical-grade digital therapeutics.
LumosityRx adapts 13 cognitive training games from the consumer platform to target attention-related processes. In a U.S. clinical trial involving over 500 patients, the app demonstrated significant improvements in sustained and selective attention, impulse control, and response consistency, which are key measures in ADHD assessment. About 44% of users achieved statistically significant gains.
This milestone follows Lumos Labs’ 2016 settlement with the FTC over misleading claims about preventing cognitive decline. With LumosityRx, the company aims to leverage its core technology to support ADHD management through evidence-based digital therapy.
