MFDS authorization
23-511 · Innovative device No. 25
Products
From prescription treatment software
to digital combination drugs
Explore prescription software for insomnia and eating disorders, alongside medication-linked technologies in development.
Insomnia · Prescription DTx
SleepQ®
Six weeks of cognitive behavioral therapy
Korea’s first integrated reviewInsurance listingCE marked
MFDS authorization 23-511↗
Eating disorders · Prescription DTxSerenQ®
Eight sessions of cognitive behavioral therapy
MFDS authorizedNET certification
MFDS authorization 25-346↗
SleepQ® milestones
SleepQ®: Korea’s first integrated innovative-device review
First integrated review
A pathway from authorization to clinical use
Prescribing and evaluation fees
TU001 prescribing · TU002 evaluation · TX010 use fee (non-covered)
Nationwide prescribing
Full-scale commercial rollout to hospitals
The SleepQ® usage fee is a recognized non-covered item, distinct from National Health Insurance benefit coverage. Confirm charges with the provider and private coverage with your insurer.
HIRA guidance ↗Digital combination drug
After a prescription,
software stays alongside
We develop digital combination drugs with pharmaceutical companies.
Explore combination drugs