The EU AI Act's postponement rewards those who never started
The EU AI Act's high-risk deadline just moved to December 2027. Under Article 111's grandfather clause, companies that never started compliance may get a permanent pass, while those who invested early carry the cost. Part 2 of a series on the disparity AI regulation is creating.
PFAS: wait-and-see Vs precautionary principle
When data is limited, do you default to safety or wait for proof of harm? This post explores the widening regulatory gap between the US and EU regarding PFAS - the "Forever Chemicals."
FDA’s new guidance on general wellness
This post critiques the widening regulatory gap between the US and EU following the FDA's new wellness guidance, highlighting how lower barriers for bold health claims in the US may sacrifice essential quality drivers and complicate global strategies for startups.
MDR/IVDR proposal for simplication
This post highlights the European Commission's groundbreaking proposal to overhaul and simplify the MDR and IVDR frameworks, promising more proportionate rules for low-risk devices, reduced administrative burdens for SMEs, and a modern, digital-first approach to medtech regulation in the EU.
What can we learn from… Canada?
This post explores the "Canadian Technology Accelerator" model for international expansion, sharing insights from a bilingual FemTech panel in Paris on how high-potential startups - like PCOS-focused mentee Élan Healthcare - can leverage diplomatic networks and local mentorship to navigate global regulatory compliance.
