With the popularity of healthcare apps linked to wearable devices exploding in Korea, a government-affiliated medical research institute in the country is recommending authorities establish guidelines to ensure the apps are accurate, reliable, and effective. The Korea Health Industry Development Institute (KHIDI)... Read More
As medical software to treat, diagnose, cure or prevent disease becomes more developed, Korean regulators are increasingly approving clinical trials of such Software as a Medical Device (SaMD) technologies. Last year, the country’s Ministry of Food and Drug Safety approved 21 SaMD... Read More
With software-driven therapeutic interventions for patient treatments known as digital therapeutics (DTx) beginning to make a mark in the world of patient care, the government of South Korea is beginning to lay the groundwork for the entrance of the technologies into its... Read More
Two months after Korea announced a new system that puts private review boards in charge of ensuring that advertisements for medical devices in Korea adhere to government standards, the scope of the reviews and details of the application process is beginning to... Read More
Advances in the use of artificial intelligence (AI) are fueling significant improvements in the field of radiology in Singapore, South Korea, and Australia, a new study has found. Eight in ten radiologists surveyed by health data firm Royal Phillips this year... Read More
Almost a year after Korea’s highest court ruled it unconstitutional for the government to require preliminary approval of advertisements for medical devices, the Ministry of Food and Drug Safety (MFDS) has announced that private review boards will review ads going forward and... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
With cancer a leading cause of death in Korea, the government plans to harness the power of big data to tackle the disease by increasing information sharing among healthcare institutions to bolster diagnosis, treatment, and research. At a meeting of the Korea... Read More
To speed the import of key new biologic agents needed to combat public health emergencies, including vaccines to help the body develop immunity to the virus that causes COVID-19, South Korea is cutting the steps required for regulatory approval of the products. The... Read More
The combination of a relatively low–cost workforce and increasingly reliable quality and ethical standards is turning the Asia-Pacific region into a hub for clinical trials. With pharmaceutical firms under growing pressure to provide innovative new products at reasonable prices, the region is becoming more... Read More