| reSET | Pear Therapeutics, Inc. | Substance use disorder (SUD) — adjunct to outpatient therapy | De Novo 2017-09-14 | Not covered (experimental / investigational) |
| reSET-O | Pear Therapeutics, Inc. | Opioid use disorder (OUD) — adjunct to outpatient treatment | 510(k) 2018-12-10 | Not covered (experimental / investigational) |
| Somryst | Pear Therapeutics, Inc. | Chronic insomnia — digital CBT-I | 510(k) 2020-03-23 | Not covered (experimental / investigational) |
| EndeavorRx | Akili Interactive Labs, Inc. | ADHD, inattentive or combined type, ages 8–17 | De Novo 2020-06-15 (+1 later) | Not covered (experimental / investigational) |
| EndeavorOTC | Akili Interactive Labs, Inc. | ADHD in adults — over-the-counter | 510(k) 2024-06-14 | Not addressed by the policy |
| Rejoyn | Otsuka America Pharmaceutical, Inc. | Major depressive disorder — adjunct to antidepressants, ages 22+ | 510(k) 2024-03-30 | Not addressed by the policy |
| MamaLift Plus | Curio Digital Therapeutics, Inc. | Postpartum depression, mild to moderate | 510(k) 2024-04-22 | Not addressed by the policy |
| SleepioRx | Big Health, Inc. | Chronic insomnia — digital CBT-I | 510(k) 2024-08-05 | Not covered (experimental / investigational) |
| DaylightRx | Big Health, Inc. | Generalized anxiety disorder — digital CBT | 510(k) 2024-08-30 | Not covered (experimental / investigational) |