The EU’s Medical Device Coordination Group (MDCG) posted two guidances in the waning weeks of 2025, one of which deals with postmarket surveillance for both devices and diagnostics. Another guidance deals with breakthrough devices (BtX) and diagnostics, a question that is not well described in either of the current EU regulatory frameworks.

Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.

Jacobio Pharmaceuticals Group Co. Ltd. is outlicensing its phase I pan-KRAS inhibitor, JAB-23E73, to Astrazeneca plc in a global deal worth up to $1.915 billion that gives Astrazeneca global rights to the compound outside of China, and the two companies will jointly develop and commercialize the asset in China.

The long-running dispute over rebates on sales of drugs that the pharma industry must pay to the U.K. government took a turn for the worse at the start of 2025, when it transpired that the rate would be going up from 15.3% to 22.9%. The row continued for most of the rest of the year before a truce of sorts was called in December.

Jacobio Pharmaceuticals Group Co. Ltd. is outlicensing its phase I pan-KRAS inhibitor, JAB-23E73, to Astrazeneca plc in a global deal worth up to $1.915 billion that gives Astrazeneca global rights to the compound outside of China, and the two companies will jointly develop and commercialize the asset in China.

The year 2025 will go down in med-tech history as remarkable for a number of things, but manufacturers doing business in the EU might be forgiven for thinking that it was a year for correction of self-inflicted wounds, even if those corrections won’t arrive in full form until 2026.

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.

Ultromics Ltd. secured a strategic investment from the American Heart Association's Go Red for Women Venture Fund to advance the use of its technology to help clinicians better identify women suffering from heart failure with preserved ejection fraction (HFpEF). The condition goes undiagnosed in millions of women, who are disproportionately affected by HFpEF. Ultromics’ Echogo Heart Failure software analyzes routine ultrasound scans to quantify heart function and identify patterns that signal HFpEF.  

The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.