As the use of digital therapeutic technologies (DTx) grows in Korea, investment in the technologies is on the rise, and government regulators are taking a closer look at how to evaluate and ensure the safety and performance of the products.
In December, the Ministry of Food and Drug Safety published guidelines for performing clinical trials of DTx products.
The technologies, which include software as a medical device (SaMD) applications, deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders, including insomnia, diabetes and addiction.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.