Prenaital ApS has filed a patent for technology that may identify risks of spontaneous pre-term birth. Spontaneous preterm birth (sPTB) is usually defined as birth occurring before 37 weeks of gestation. The invention relates to a method for predicting potential preterm birth from medical scan data, which may be used in practice by medical professionals for risk analysis and prognosis of potential pathologies.

Microsurgery is performed to connect small human vessels, but the technical difficulty required to conduct this type of surgery is quite specialized and limits the number of surgeons who can perform microsurgery.

Perhaps the biggest indicator of U.S. President Donald Trump’s activism in his second term is the 225 executive orders (EOs) he issued in 2025. The pace of those orders seems to have slowed, with “only” 16 released in the last quarter of the year. Four of the recent EOs could impact drug and device companies in a myriad of ways.

Generative AI has largely escaped the U.S. FDA’s regulatory purview up to now, but OpenAI seems poised to create a new source of regulatory angst for the agency. The company unveiled its ChatGPT Health Jan. 7, a large language model that when used professionally could land the company in the FDA’s regulatory crosshairs.

It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.

South Korea’s National Assembly approved the largest budgets for its health ministries in 2026, including the Ministry of Health and Welfare, Ministry of Food and Drug Safety and Korea Disease Control and Prevention Agency.

Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction.

The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.

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.