ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Different types of digital therapeutics14-25)
| Classification | Device (FDA Approval Code) | Applicant | FDA approval | EU CE Mark | Target | Software form |
|---|---|---|---|---|---|---|
| Standalone | EndeavorRx® (DEN200026) | Akili Interactive | ○ | ○ | ADHD | Game |
| Nightware® (DEN200033) | Nightware | ○ | × | Nightmare from PTSD | Applewatch program | |
| Natural Cycles® (DEN170052) | NaturalCycles | ○ | ○ | Contraception | Smartphone application | |
| EaseVRx® (DEN210014) | AppliedVR | △ | × | Chronic lower back-pain | VR | |
| reSET® (DEN160018) | Pear Therapeutics | ○ | × | SUD | Smartphone application | |
| reSET-O® (K173681) | OUD | |||||
| Somryst® (K191716) | Insomnia | |||||
| Complementary | Insulia® (K202596) | Voluntis | ○ | ○ | Type2 diabetes | Smartphone application/Web portal |
| Bluestar® (K203434) | WellDoC | ○ | × | Type2 diabetes | Smartphone application/Web portal | |
| Augment | Freespira® (K180173) | Palo Alto Health Sciences, Inc. | ○ | × | PD/PTSD | Bio feedback device |
| Propeller Sensor® (K192724) | Reciprocal Labs Corporation | ○ | ○ | COPD | Smartphone application |
ADHD: attention deficit hyperactivity disorder; PTSD: post traumatic stress disorder; VR: virtual reality; SUD: substance use disorder; OUD: oipoid use disorder; PD: panic disorder; COPD: chronic obstructive lung disease
△: De novo is under way (2022.08.26.)