The final text of the AI Act is now available for all to read but, for medtech, it may feel that work is only just beginning.
The text of the EU’s AI Act, which lays the foundation for responsible development of AI across all industrial sectors, was published in the Official Journal of the EU on 13 July and is due to enter into force on 2 August.
The deadline for the application of Regulation (EU) 2024/1689 to AI-enabled medical technologies already regulated under the Medical Device
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Dexcom’s relatively strong position amid tariff-related uncertainty is rooted in its long-standing investments in domestic manufacturing, but raw material inflation is driving cost concerns even in the face of operational efficiencies.
