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FDA

First OTC Video Game to Gain FDA Approval

20th June 2024

The FDA has authorised a video game on mobile phones made by Akali intended to treat ADHD for sale. This is the very first occasion that an OTC video game was officially approved by the agency.

The game, named EndeavorOTC, was approved by the FDA under the 510(k) process following a clinical study in which 83% of the participants showed a clinical response after receiving the therapy.

Using the Adult ADHD Quality of Life Scale, approximately three-quarters (72.5%) of the participants in the STARS-ADHD-Adult study indicated at least a slight boost in their standard of life (QoL). An additional 45.8% of patients achieved a level of improvement that was deemed clinically relevant.

CEO of Akili, Matt Franklin stated: “This FDA authorisation of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we’re incredibly proud of pioneering a new tier of digital medicine.

He continued: “This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals. We are particularly grateful to the patients who participated in the study that made this clearance possible.”

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