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BioWorld - Friday, December 12, 2025
Home » Topics » Regulatory » MOHW

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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Feb. 4, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
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Ribbons of digital data

South Korea issues world’s first generative AI medical device guideline

Jan. 24, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
Read More
Omniabio building

Medipost grows US, Canada base; plans US phase III of Cartistem

Jan. 21, 2025
By Marian (YoonJee) Chu
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
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Twindemic diagnostic

Incheon team mints new diagnostic test tailored to ‘twindemics’

Jan. 16, 2025
By Marian (YoonJee) Chu
Researchers have developed a novel point of care (POC) diagnostic that can test for multiple respiratory viral infections simultaneously, including for the flu and COVID-19. The POC diagnostic tool leverages a novel, non-enzymatic signal amplification method, according to study lead Eunjung Kim, professor at Incheon National University (INU), whose team published the findings in Sensors and Actuators B: Chemical online November 2024.
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Omniabio building

Medipost grows US, Canada base; plans US phase III of Cartistem

Jan. 15, 2025
By Marian (YoonJee) Chu
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
Read More
Purple-tinted test tubes and dropper

South Korea ups 2025 health agency budget, biomedical R&D funds

Jan. 7, 2025
By Marian (YoonJee) Chu
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
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Purple-tinted test tubes and dropper

South Korea ups 2025 health agency budget, biomedical R&D funds

Jan. 7, 2025
By Marian (YoonJee) Chu
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
Read More
Purple-tinted test tubes and dropper

South Korea ups 2025 health agency budget, biomedical R&D funds

Jan. 6, 2025
By Marian (YoonJee) Chu
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
Read More
Globe showing Asia-Pacific region
Year in review

AI drives financings, approvals for APAC med-tech in 2024

Dec. 27, 2024
By Marian (YoonJee) Chu
AI pulled in major financings and approvals for Asia med-techs in 2024 as Asia Pacific countries played to individual strengths to maximize AI’s applications in the health care sector. While breakaway AI technologies like OpenAI’s ChatGPT reshaped and boosted many industries, AI also drove major financings for APAC med-techs weathering a wider macroeconomic downturn, with AI-based companies accounting for five out of 11 IPOs tracked on BioWorld’s med-tech IPOs list.
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Acryl

Acryl cleared as Korea’s first AI DTx to screen, diagnose depression

Dec. 23, 2024
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.
Read More
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