1. Pink Sheet
  2. >>Geography
  3. >>Asia
  4. >>South Korea

Aimmed’s Insomnia App Approved As Korea’s First Digital Therapeutic

But Reimbursement Decision May Take Time

 
• By Jung Won Shin

More approvals of digital therapeutics are expected to come in the wake of South Korea's first approval of this type of product, Aimmed’s insomnia mobile app Somzz. But reimbursement decisions on such therapies could take months and will be closely monitored going forward.

insomnia
Somzz Becomes First Approved Digital Therapeutic In Korea • Source: Shutterstock

South Korea’s Ministry of Food and Drug Safety (MFDS) has approved Aimmed Co. Ltd.’s cognitive treatment software Somzz as the country’s first digital therapeutic, paving the way for use of such products in the treatment of various diseases and disorders.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from South Korea

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.

Korea ‘Guide’ Program To Speed Select Innovative Products To Market

 
• By Jung Won Shin

In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.

2024 Korea Regulatory Highlights And What’s In Store For This Year

 
• By Jung Won Shin

The Pink Sheet looks at what major policies and regulations South Korean authorities prioritized in 2024 and what may be in store for this year.

More from Asia

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?