Parallel
IBS
EndeavorRx
ADHD
NightWare
PTSD
reSET
Substance
use disorder
CureApp SC
Smoking cessation
Vivira
Pain
Selfapys
Mental Illness
Mika
QOL and psychological/
psychosomatic issues from cancer diagnoses
Rehappy
TIA stroke; SAH or
intracerebral bleeding/
hemorrhagic stroke
Kalmeda
Tinnitus
Tinnitus
Zanadio
Obesity
Mindable
Panic & agoraphobia
M-sense Migräne
Migraine
Somnio
Insomnia
Elevida
Fatigue in Multiple
Sclerosis
Velibra
Anxiety disorder /
panic / agoraphobia
Deprexis
Depression
Vorvida
Alcohol use disorder
SilverCloud/ Space
from Depression
Mental health and
behavioral disorders
Kaia Health
Musculoskeletal pain
Pivot Program
Smoking cessation
MindMotion GO
Neuro-rehabilitation
Freespira
Panic attack
symptoms; PTSD
reSET-O
Opioid use
disorder
Somryst
Chronic insomnia
Approved Digital Therapeutics
Hover over each bubble
to learn more
CureApp SC
Mobile application
Approval pathway:
MHLW (Japan)
By prescription in some countries
Single randomized controlled trial
Interventional (non RCT) trial run
Delivers cognitive behavioral therapy
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•
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Vivira
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Two randomized controlled trials
Real world data generated
•
•
•
Selfapys
Web application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Two randomized controlled trials
Delivers cognitive behavioral therapy
•
•
•
Mika
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Two randomized controlled trials
•
•
Rehappy
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
•
•
Kalmeda Tinnitus
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
Delivers cognitive behavioral therapy
•
•
•
Zanadio
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
•
•
Mindable
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Two randomized controlled trials
Delivers cognitive behavioral therapy
•
•
•
M-sense Migräine
Mobile application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
•
•
Somnio
Mobile application / Web application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Two randomized controlled trials
Permanent addition to the DiGA directory
Delivers cognitive behavioral therapy
•
•
•
•
Elevida
Web application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
Permanent addition to the DiGA directory
Delivers cognitive behavioral therapy
•
•
•
•
Velibra
Mobile application / Web application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
Permanent addition to the DiGA directory
Delivers cognitive behavioral therapy
•
•
•
•
Deprexis
Web application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
More than two randomized controlled trials
Cost effectiveness data generated
Permanent addition to the DiGA directory
Delivers cognitive behavioral therapy
•
•
•
•
•
Vorvida
Web application
Approval pathway:
CE Mark and DiGA (Germany)
By prescription in some countries
Single randomized controlled trial
Permanent addition to the DiGA directory
Delivers cognitive behavioral therapy
•
•
•
•
SilverCloud/
Space from Depression
Mobile application / Web application
Approval pathway:
CE Mark via MDD/MDR (EU)
More than two randomized controlled trials
Cost effectiveness data generated
Interventional (non RCT) trial run
Delivers cognitive behavioral therapy
•
•
•
•
Kaia Health
Mobile application
Approval pathway:
CE Mark via MDD/MDR (EU)
More than two randomized controlled trials
Real world data generated
•
•
Pivot Program
Mobile application
Approval pathways:
FDA 510(k) Premarket (US)
CE Mark via MDD/MDR (EU)
Interventional (non RCT) trial run
•
MindMotion GO
Game
Approval Pathways:
FDA 510(k) Premarket (US)
CE Mark via MDD/MDR (EU)
Real world data generated
Interventional (non RCT) trial run
•
•
Freespira
Mobile application
Approval Pathway:
FDA 510(k) Premarket (US)
Single randomized controlled trial
Cost effectiveness data generated
Interventional (non RCT) trial run
•
•
•
reSET-O
Mobile application
Approval Pathway:
FDA 510(k) Premarket (US)
Designated part of Breakthrough Devices Program or Expedited Access Pathway
By prescription in some countries
Two randomized controlled trials
Interventional (non RCT) trial run
Delivers cognitive behavioral therapy
•
•
•
•
•
Somryst
Mobile application
Approval Pathway:
FDA 510(k) Premarket (US)
By prescription in some countries
Two randomized controlled trials
Interventional (non RCT) trial run
Delivers cognitive behavioral therapy
•
•
•
•
EndeavorRx
Game
Approval Pathways:
FDA De Novo (US)
CE Mark via MDD/MDR (EU)
Received Emergency Use Authorization
By prescription in some countries
More than two randomized controlled trials
•
•
•
Parallel
Web application
Approval Pathways:
FDA De Novo (US)
CE Mark via MDD/MDR (EU)
By prescription in some countries
More than two randomized controlled trials
Cost effectiveness data generated
Interventional (non RCT) trial run
•
•
•
•
NightWare
Mobile application
Approval Pathway:
FDA De Novo (US)
Designated part of Breakthrough Devices Program or Expedited Access Pathway
By prescription in some countries
More than two randomized controlled trials
Interventional (non RCT) trial run
•
•
•
•
reSET
Mobile application
Approval Pathway:
FDA De Novo (US)
By prescription in some countries
Two randomized controlled trials
Interventional (non RCT) trial run
Delivers cognitive behavioral therapy
•
•
•
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