Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearpoint Neuro, Medtronic, Rhythm AI.
Abbott Laboratories reported fourth quarter sales below expectations before the market opened on Jan. 22, sending the stock down nearly 12% from the prior day's closing. The biggest hits came from contraction in the nutrition group along with continued disruption in the diagnostics unit from volume-based procurement in China. Medical devices suffered from market share loss in electrophysiology and slower than expected uptake of continuous glucose monitors. The pharma group performed as anticipated, posting 7% growth.
A team of international researchers is investigating whether a finger-prick blood test could be used to help diagnose Alzheimer’s disease before symptoms appear. With current diagnostic methods relying on expensive brain scans and invasive lumbar punctures, the trial is exploring whether the simple test could offer a faster, cheaper, and more accessible route to identifying the disease.
The European Commission recently published the results of a study of the impact of the EU regulatory environment, which confirmed the worst fears of some observers about the situation in the EU. The report said that the associated challenges are prompting small and medium companies to pull at least one product out of inventory for the EU market, with some companies abandoning the EU altogether.
Med-tech M&A activity cooled in 2025, with total reported deal value falling to about $42.14 billion, down from $57.9 billion in 2024 and far below the levels seen in 2021 and 2022, when annual totals exceeded $150 billion.