Zylox-Tonbridge Medical Technology Co. Ltd. plans to expand globally with M&As, company chairman and CEO Jonathon Zhong Zhao told BioWorld, starting with a stepwise acquisition of Optimed Holding GmbH and its subsidiaries, including Optimed Medizinische Instrumente GmbH.

Third-party litigation funding in Europe has created enough of a stir that several trade associations issued a joint statement making the case that the unregulated nature of these funding agreements is increasing the cost of doing business in a region that is already quite expensive.

The U.S. FDA’s October 2025 draft guidance for quality management system information in premarket filings may have struck some observers as an example of regulatory overreach, given the robust opposition to several key aspects of the draft on the parts of the Advanced Medical Technology Association and the Medical Device Manufacturers Association.

Epidarex Capital secured more than $145 million in commitments in the first close of its fourth fund to invest in early-stage therapeutics and medical device companies. The new capital will support up to 15 companies, across the U.K. and U.S., which are focused on oncology, cardiovascular, autoimmune and neurological conditions.

Beta Bionics Inc.’s preliminary results for its first full year as a public company offered an early read on developments and market positioning in the insulin pump and patch market, with analysts pointing to steady growth, rising pharmacy channel penetration and intensifying pressure as more products target both type 1 and type 2 diabetes.

The U.S. FDA’s Center for Biologics Evaluation and Research posted four warning letters to makers of HIV sample collection kits, an example of a shift in FDA enforcement in the IVD space that is still allowed after a historical loss in court.