Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.

It was in with the new and out with the old Jan. 3 as the gavel came down on the first session of the 119th U.S. Congress. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S.

Balt Group SAS recently secured €355 million (US$365 million) in funding to refinance its debt, invest in research and accelerate its growth. The French-based provider of interventional neuroradiology devices is looking to speed up the expansion of its global footprint, especially in the U.S.

Med-tech deals activity dropped significantly in 2024, falling 84% from $9.83 billion in the first nine months of 2023 to $1.6 billion in the same period this year. While down from $6.59 billion in Q1 to Q3 2022, value is higher than $979.84 million in the comparable period in 2021.

Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.

Med-tech companies raised $25.36 billion in financings in 2024, marking a 43% increase from $17.68 billion in 2023. December saw a significant rise, with $1.72 billion raised, compared to $919.99 million in November.