Skip to content
ContentLora

    Tip: press / anywhere to search.

    Explainer

    ADHD apps and digital therapeutics: a sourced guide (2026)

    As of October 2026, FDA's records for ADHD digital therapeutic software list four decisions, covering EndeavorRx for children and teenagers, EndeavorOTC and Prismira for adults; a separate nerve-stimulation device, Monarch eTNS, is authorised for children aged 7 to 12.[1][2] Their evidence rests mainly on a computerised attention test rather than everyday behaviour, and Prismira's average gain was below the threshold its own submission called clinically important.[3][4]

    Editor reviewedStrict sourcingUpdated ExplainerMental health, Health and medicine, Neuroscience and brain-computer interfaces

    Many apps are marketed to people with ADHD, but only a handful of digital products have been reviewed by FDA as ADHD treatments.[1] This guide covers those products and the evidence submitted for them, and points out warning signs from recent enforcement cases against ADHD telehealth companies.

    How this guide works: ContentLora does no hands-on testing. We did not use any of these products. We compare regulators’ records, manufacturers’ published labelling and prices, and peer-reviewed trials, and cite each claim. Prices are as listed on the date shown and may change. There are no affiliate links.

    This guide is not medical advice. These products are prescribed or used alongside clinical care; talk to a doctor or other clinician about whether any of them suits you or your child.

    What “FDA-authorised” means here

    FDA classifies ADHD digital therapy software as Class II medical devices: software intended to treat ADHD or its symptoms as an add-on to treatment supervised by a clinician.[5] As of 11 October 2026, FDA’s records under that category listed four decisions: EndeavorRx (2020 and 2023), EndeavorOTC (2024) and Prismira (2025).[1] General-purpose focus, planner or reminder apps sold to people with ADHD are not on that list, so FDA has not reviewed them as treatments.[1]

    Products compared

    Product (maker)TypeWho it is forFDA recordPrice checked
    EndeavorRx (Akili)Prescription video gameAges 8-17, inattentive or combined ADHD[3]De Novo June 2020; 510(k) Dec 2023[6]$99 per 30 days (11 Oct 2026)[7]
    Prismira (Lumos Labs)Prescription appAdults 22-55, inattentive or combined ADHD[8]510(k) June 2025[8]Not checked
    EndeavorOTC (Akili)Non-prescription appAdults 18+[9]510(k) cleared June 2024[10]Not checked
    Monarch eTNS (NeuroSigma)Prescription nerve-stimulation deviceAges 7-12 not on ADHD medication[2]De Novo April 2019; Gen 2.0 510(k) Jan 2024[11]Not checked

    What the evidence shows

    The game-based products were tested mainly on a computerised attention test called TOVA, not on everyday behaviour at home or school. EndeavorRx’s maker says children may not see improvements in behaviour such as hyperactivity.[3] Prismira’s trial met its goal on TOVA, but the average gain was smaller than the change its submission called clinically important.[4] Side effects reported were mild, mostly frustration and headache.[12][13]

    • EndeavorRx (AKL-T01): in the randomised STARS-ADHD trial of 348 children aged 8 to 12, mean TOVA API change was 0.93 with the game versus 0.03 with a digital control over four weeks. Akili sponsored the trial.[14] Further trials enrolled 162 adolescents and 221 adults, and a 2024 analysis of them was written by current or former Akili employees.[15] Across the two trials supporting the 8-17 indication, 4.97% of 342 users had treatment-related adverse events.[12]
    • Prismira: the sham-controlled GAMES trial enrolled 560 adults and analysed 456. The 1.09-point TOVA gain was statistically significant but below the 1.4-point minimal clinically important difference. Secondary symptom scales showed no statistically meaningful between-group differences, though a clinician global rating favoured the app.[4] Adverse events occurred in 0.7% of users.[13]
    • Monarch eTNS: in a 62-child trial, ADHD-RS scores fell from 34.1 to 23.4 with the active device versus 33.7 to 27.5 with a placebo device after four weeks. Common side effects were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache and fatigue.[16][17] For how neurostimulation devices work more broadly, see our neurotech crash course.

    A note on EndeavorOTC’s website

    FDA’s 510(k) record shows EndeavorOTC (K233496) was cleared on 14 June 2024. As of October 2026 the product’s website still carried an older footer saying it “has not been cleared or authorized” by FDA, wording that predates the clearance.[10] FDA’s record is the authoritative source for a device’s status.

    Red flags from telehealth enforcement

    Some ADHD apps are really telehealth services that prescribe medicine. Two recent cases show what regulators objected to:

    • Done Global: prosecutors said its subscription model used automatic refills that minimised follow-up appointments. Its founder and clinical president were convicted in November 2025 and sentenced in July 2026.[18][19][20]
    • Cerebral: prosecutors said it gave providers financial incentives to prescribe stimulants and lacked controls against diversion. It signed a non-prosecution agreement in November 2024.[21][22]

    Warning signs drawn from those cases: prescriptions that renew automatically without regular clinician contact, and services built around getting a stimulant prescription rather than an assessment.[18][21] Legitimate telehealth prescribing of stimulants is allowed until 31 December 2026 under a temporary DEA rule.[23] See the shortage and telehealth tracker and the medication guide.

    Next in the crash course

    Questions readers ask

    Is there an FDA-approved video game for ADHD?

    FDA granted EndeavorRx a De Novo authorisation in June 2020. It is indicated to improve attention function, as measured by computer-based testing, in children aged 8 to 17 with primarily inattentive or combined-type ADHD.[6][3]

    How much does EndeavorRx cost?

    As of 11 October 2026, the maker listed EndeavorRx at $99 for a 30-day prescription, payable with FSA or HSA funds.[7]

    Is there an FDA-cleared ADHD app for adults?

    FDA cleared Lumos Labs' Prismira in June 2025 as a prescription digital therapeutic for adults aged 22 to 55. FDA also cleared Akili's EndeavorOTC for adults in June 2024, as a non-prescription app.[8][10]

    Do ADHD digital therapeutics replace medication?

    No. FDA defines ADHD digital therapy software as an adjunct to clinician-supervised treatment, and EndeavorRx's labelling says it should be part of a programme that may include therapy, medication and educational support.[5][3]

    How well do these apps work?

    In trials they improved scores on a computerised attention test (TOVA). EndeavorRx's maker says patients may not see benefits in behavioural symptoms such as hyperactivity, and Prismira's average improvement was below the minimal clinically important difference cited in its FDA submission.[14][3][4]

    What is the Monarch eTNS device?

    A prescription device that sends low-level electrical stimulation to the trigeminal nerve through a forehead patch, authorised by FDA in 2019 for children aged 7 to 12 not taking ADHD medication. In its 62-child trial, symptom scores fell more with the active device than with a placebo device.[2][16]

    Sources

    · 23 claims from 14 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      As of 11 October 2026, FDA's records under the product code for ADHD digital therapeutic software (QFT) listed four marketing decisions - EndeavorRx (De Novo 2020 and a 2023 510(k)), EndeavorOTC (2024) and Lumos Labs' Prismira (2025). confirmedas of 2026-10-11

    2. [2]

      On 19 April 2019 FDA permitted marketing of the Monarch external Trigeminal Nerve Stimulation (eTNS) System, a prescription-only device for children aged 7 to 12 not taking ADHD medication and the first non-drug ADHD treatment FDA authorised. confirmedas of 2019-04-19

    3. [3]

      EndeavorRx is indicated to improve attention function, as measured by computer-based testing, in children aged 8 to 17 with primarily inattentive or combined-type ADHD; its labelling says patients may not see benefits in behavioural symptoms such as hyperactivity. confirmedas of 2026-10-11

      • EndeavorRx: indications, safety and cost · Akili Interactive Labs (manufacturer) · Indications, Safety and Cautions; also: "may not display benefits in typical behavioral symptoms, such as hyperactivity" (retrieved 2026-10-11)
    4. [4]

      In Prismira's pivotal GAMES trial (560 adults enrolled, 456 analysed), the improvement on the TOVA attention score was statistically significant versus a sham control, but the 1.09-point mean gain was below the 1.4-point minimal clinically important difference, and secondary symptom scales showed no statistically meaningful differences between groups. confirmedas of 2025-06-13

    5. [5]

      FDA classifies ADHD digital therapy software as Class II devices, defined as software intended to provide therapy for ADHD or its symptoms as an adjunct to clinician-supervised treatment. confirmedas of 2026-10-11

    6. [6]

      FDA granted Akili Interactive's EndeavorRx a De Novo classification as a digital therapeutic for ADHD on 15 June 2020, and cleared an updated EndeavorRx through a 510(k) (K231337) on 13 December 2023. confirmedas of 2026-10-11

    7. [7]

      As of 11 October 2026, Akili listed EndeavorRx at $99 for a 30-day prescription, payable with FSA or HSA funds. confirmedas of 2026-10-11

    8. [8]

      FDA cleared Lumos Labs' Prismira (K243729) on 13 June 2025 as a prescription digital therapeutic to improve attention function in adults aged 22 to 55 with primarily inattentive or combined-type ADHD, using EndeavorRx as the predicate device. confirmedas of 2025-06-13

    9. [9]

      Akili describes EndeavorOTC as a digital therapeutic to improve attention, ADHD symptoms and quality of life in adults aged 18 and older with primarily inattentive or combined-type ADHD. confirmedas of 2026-10-11

    10. [10]

      FDA cleared EndeavorOTC (510(k) K233496, Akili Interactive Labs) on 14 June 2024 under product code QFT. As of 11 October 2026 the product's website still carried an older footer saying it "has not been cleared or authorized" by FDA, which predates that clearance. confirmedas of 2026-10-11

    11. [11]

      FDA cleared a Generation 2.0 Monarch eTNS System through a 510(k) (K233293) on 16 January 2024. confirmedas of 2024-01-16

    12. [12]

      Akili reports that of 342 participants who used the EndeavorRx software in the two trials supporting its 8-17 authorisation, 4.97% had treatment-related adverse events, mainly decreased frustration tolerance (2.34%) and headache (1.17%), with no serious adverse events. confirmedas of 2026-10-11

    13. [13]

      In the Prismira trial, 2 of 275 people using the active software (0.7%) reported treatment-related adverse events, both decreased frustration tolerance, and there were no serious adverse events. confirmedas of 2025-06-13

    14. [14]

      In the industry-sponsored STARS-ADHD randomised trial of 348 children aged 8 to 12, the EndeavorRx software (AKL-T01) improved a computerised attention score (TOVA API) by a mean 0.93 versus 0.03 for a digital control over four weeks. confirmedas of 2020-02-24

    15. [15]

      Further AKL-T01 trials enrolled 162 adolescents aged 13 to 17 and 221 adults, and the authors of a 2024 analysis of these trials were current or former Akili employees. confirmedas of 2024-08-11

    16. [16]

      In the 62-child trial supporting Monarch eTNS, average ADHD-RS scores fell from 34.1 to 23.4 with the active device versus 33.7 to 27.5 with a placebo device after four weeks. confirmedas of 2019-04-19

    17. [17]

      FDA listed the most common side effects of Monarch eTNS as drowsiness, increased appetite, trouble sleeping, teeth clenching, headache and fatigue, with no serious adverse events. confirmedas of 2019-04-19

    18. [18]

      Prosecutors said Done used a subscription model with automatic refills, through which prescribers signed Adderall refills based on automatically generated messages, minimising follow-up appointments. confirmedas of 2026-07-07

    19. [19]

      In November 2025 a federal jury convicted Done Global founder Ruthia He and former clinical president David Brody of conspiracy to distribute controlled substances, distribution of controlled substances and conspiracy to commit health care fraud; He was also convicted of conspiracy to obstruct justice. confirmedas of 2026-07-07

    20. [20]

      On 7 July 2026 He was sentenced to six years in prison and a $1 million fine, and Brody to two years in prison and a $1 million fine. confirmedas of 2026-07-07

    21. [21]

      The US Attorney's Office said Cerebral gave providers financial incentives for prescribing stimulant medication to ADHD patients and did not keep adequate controls against diversion, and Cerebral admitted to the facts in a statement attached to the agreement. confirmedas of 2024-11-06

    22. [22]

      On 4 November 2024 telehealth company Cerebral signed a non-prosecution agreement with the US Attorney's Office for the Eastern District of New York, agreeing to forfeit $3.65 million, with a further $2.92 million fine deferred and waived if it complies. confirmedas of 2024-11-06

    23. [23]

      On 31 December 2025 DEA and HHS published a fourth extension of the telemedicine flexibilities, effective 1 January 2026 through 31 December 2026. confirmedas of 2025-12-31

    Revision history (1)
    1. Page created.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Jan 11, 2027.

    Cite this page

    "ADHD apps and digital therapeutics: a sourced guide (2026)." ContentLora, updated Oct 11, 2026. https://contentlora.com/explain/adhd-apps-and-digital-therapeutics-guide

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

    ☰ Contents