Table 3.
Identified technologies with FDA approval.
| Technology (Manufacturer) | Number of Trials (Date Range of Trial) Condition (Year of Latest Trial): Development Stage |
Type of Technology | Type of Device | Invasive? | AI Component? | Intended Setting | Place in Pathway | Digital Health Technology Category |
|---|---|---|---|---|---|---|---|---|
| Neuro-Omega System (Alpha Omega Engineering) | Parkinson’s disease (2017): Stage 3 | DBS | Surgical | Hospital | Treatment | Digital therapeutics | ||
| NeuroPort Array (Blackrock Neurotech) | Spinal cord injury (2013): Stage 1 | BCI | Implantable | Hospital | Treatment | |||
| Vercise (Boston Scientific) | 12 trials (2010–2025) Parkinson’s disease (2020): Stage 3 Alzheimer’s disease (2025): Stage 1 Depression: (2018): Stage 2 |
DBS | Implantable | Hospital | Treatment | |||
| EGI Geodesic N400 System (Electrical Geodesics) | Stroke * | EEG | Wearable | Hospital | Rehabilitation | Patient monitoring | ||
| Rehastim 2 (HASOMED) | Stroke † | BCI | External device | Home | Treatment | Digital therapeutics | ||
| SAINT (Magnus Medical) | 2 trials (2023–2024) Major depressive disorder (2023): Stage 4 |
TMS | Wearable | Home | Treatment | Digital therapeutics | ||
| Magstim 2002 (Magstim) | 2 trials (2013–2010) Parkinson’s disease (2010): Stage 2 |
rTMS | Wearable | Hospital | Treatment | |||
| Magstim Rapid2 (Magstim) | 16 trials (2007–2023) Stroke (2023): Stage 2 Spinal cord injury (2016): Stage 1 Alzheimer’s disease (2012): Stage 2 Parkinson’s disease (2015): Stage 2 Depression (2012): Stage 2 Neuropathic pain (2022): Stage 2 Bipolar depression (2012): Stage 1 |
rTMS | Wearable | Hospital | Treatment | |||
| StimGuide (Magstim) | Major depressive disorder (2019): Stage 2 | TMS | Wearable | Hospital | Treatment | Digital therapeutics | ||
| MagPro R30 (MagVenture) | 10 trials (2015–2024) Depression (2024): Stage 3 Bipolar depression (2023): Stage 2 Alzheimer’s disease (2023): Stage 3 |
TMS/TBS | External device | Hospital | Treatment | |||
| MagPro X100 (MagVenture) | 11 trials (2010–2024) Stroke (2010): Stage 1 Depression (2024): Stage 4 Alzheimer’s disease (2023): Stage 3 |
TMS | External device | Hospital | Treatment | |||
| Activa (Medtronic) | 20 trials (2005–2017) Depression (2014): Stage 1 Spinal cord injury (2015): Stage 1 Alzheimer’s disease (2012): Stage 1 Parkinson’s disease (2017): Stage 4 |
DBS | Implantable | Hospital | Treatment | |||
| Percept (Medtronic) | 8 trials (2013–2023) Parkinson’s disease (2023): Stage 4 Depression (2023): Stage 1 Spinal cord injury (2021): Stage 1 |
DBS | Implantable | Hospital | Treatment | Digital therapeutics | ||
| Relivion (Neurolief) | Major depressive disorder †† | Unknown | Wearable | Home | Treatment | Digital therapeutics | ||
| NeuroStar TMS (Neuronetics) | 4 trials (2011–2020) Major depressive disorder (2020): Stage 4 |
TMS | Wearable | Hospital | Treatment | Digital therapeutics | ||
| NeuroPace RNS System (NeuroPace) | 1 trial (2019) Depression (2019): Stage 4 |
DBS | Surgical | Hospital | Treatment | Digital therapeutics | ||
| eXimia NBS System (NeuroPace) | 1 trial (2009) Stroke (2009): Stage 1 |
TMS | Wearable | Hospital | Rehabilitation | Digital therapeutics |
Key: * conference paper; † journal article; †† news.