Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to go about their days without frequent, hours-long visits to a dialysis clinic or being hooked up to a filtration system at home.

Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in the first half.

Epiminder Ltd. raised AU$125 million (US$82.99 million) in its initial public offering on the Australian Securities Exchange to commercialize its Minder system, a long-term ambulatory electroencephalography monitoring device for epilepsy.

Saluda Medical Pty Ltd. announced a AU$231 million ($152.7 million) initial public offering on the Australian Securities Exchange to scale up its U.S. footprint for its Evoke spinal cord simulation system for chronic pain.

On Nov. 5, the Chinese Ministry of Commerce reported it would lift the export ban on Illumina Inc., which had been in place since March 4. While the ban will be lifted starting Nov. 10, Illumina remains on the unreliable entities list, requiring government approval for instrument purchases.

Nexgel Biotech Co. Ltd. and CG Bio Co. Ltd. agreed to co-develop a thermosensitive polyphosphazene hydrogel-based long-acting drug delivery platform through a new collaboration agreement signed Oct. 31.

The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.

The Trump administration has launched an investigation into the national security effects of imports of medical equipment, devices, consumables and equipment, laying the groundwork for a potential increase in tariffs targeting the industry. A separate investigation into robotics and industrial machinery began the same day. Med-tech stocks dropped significantly in response to the news as investors fear increased tariffs on the sector. In April, the administration initiated a similar review of the pharmaceutical industry and in August threatened 200% tariffs on that sector.

South Korea’s Ministry of Food and Drug Safety signed a confidentiality agreement with Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to boost bilateral regulatory cooperation in the field of medical devices.

Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.