EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle.

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.

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.

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.

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.

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.

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.  

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.

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.

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.