One of the sessions at this year’s Food and Drug Law Institute’s enforcement conference dealt with the use of AI for FDA compliance activities, but the question of AI legislation also arose. The problem with AI legislation, said Nathan Brown of Akin Gump, is how to manage the details of any legislation, which presents enough drag that federally preemptive legislation stands a faint chance of passage anytime soon.

Kakao Healthcare Corp. plans to secure ₩100 billion (US$68 million) through two investment deals with Cha Biomedical Group and outside investors by early next year. The transactions, expected to close by the first quarter of 2026, will make Cha the controlling shareholder of Kakao Healthcare with a 43.08% stake. Kakao Corp., the parent company, will hold 29.99%, and external investors will own 26.93%.

The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal.

The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.

A team of five members of the U.S. FDA staff published a review of the use of AI in health care and concluded that while hallucinations in AI systems can be minimized, the trade-off is that efforts to minimize hallucinations tend to diminish the AI’s performance.

UNESCO has adopted the first set of global standards on the ethics of neurotechnology amid the rapid advancement in the development of the technologies and increasing investor interest. These standards, which take effect on Nov. 12, 2025, establish safeguards to ensure that neurotechnology improves the lives of those who need it the most without compromising human rights.

Customed Ltd. has completed its seed funding round, bringing the total capital raised to $6 million. The company has developed a platform which provides orthopedic surgeons with personalized pre-surgical planning and 3D printed surgical tools. The funds will be used to support regulatory approvals in the U.S. and EU, as well as expansion into additional automated orthopedic indications.

Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.