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BioWorld - Monday, December 15, 2025
Home » Topics » Asia-Pacific, BioWorld MedTech

Asia-Pacific, BioWorld MedTech
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Toy bulldozer moving FDA letter blocks

FDA continues offensive against bogus device test results

May 28, 2025
By Mark McCarty
The U.S. FDA issued general correspondence letters to two device testing labs located in China. This is the latest in a series of moves by the agency to crack down on falsified or otherwise invalid device testing data.
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DNA NGS genome sequencing

GC Genome plans $30M IPO to diversify genomic products, suppliers

May 27, 2025
By Marian (YoonJee) Chu
No Comments
GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
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Phase HPV urine test

Phase Scientific raises $34M series A to advance urine-based diagnostics

May 20, 2025
By Tamra Sami
Phase Scientific International Ltd. raised $34 million in a series A round to accelerate research and development of its early disease detection technology for multiple cancers, women's health issues, and infectious diseases.
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Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 19, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
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Illustration of brain and brain waves, concept of focal seizure

Rebrain’s brain targeting AI secures MDR CE mark

May 16, 2025
By Shani Alexander
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
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Kakao Pasta app

Kakao Healthcare brings CGM app to Japan

May 16, 2025
By Marian (YoonJee) Chu
Step aside, Marco Polo: Kakao Healthcare Corp. plans to bring PASTA to Japan. PASTA is Kakao's AI-based continuous glucose monitoring (CGM) management mobile application, which will be available in Japan through a new subsidiary as the health care company works to expand its global presence.  
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Zip p2 platform

Zip Diagnostics develops first rapid POC test for scabies

May 16, 2025
By Tamra Sami
Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
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Ribbons of digital data

Survey says AI must overcome trust issue to transform health care

May 15, 2025
By Holland Johnson
Royal Philips NV unveiled its Future Health Index report for 2025, and it reveals the widening trust gap between health care professionals and patients concerning the adoption of AI in health care.
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Global market charts

Pause on tariffs could boost med-tech earnings

May 12, 2025
By Annette Boyle
The long-term status of the trade dispute with China remains unclear, but a 90-day reduction in stratospheric tariffs imposed by the U.S. and China on their respective products provides breathing room for the med-tech companies predicting the hardest hit from the original levels.
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Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 9, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More
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