The European Medicines Agency’s decision to host the Veterinary Medicines Info Day in a purely online format reflects both the evolving digital landscape and a cautious approach to stakeholder engagement.…
Boston Scientific’s move to acquire Penumbra is a textbook example of a company aiming to broaden its vascular surgery footprint without cannibalizing its existing portfolio. On the surface, this seems…
The recent survey by Imprivata highlighting the enthusiasm among healthcare IT leaders for passwordless authentication is both unsurprising and deeply telling. It underscores a growing awareness that traditional password-based security…
The introduction of a device capable of delivering both radiofrequency (RF) energy and pulsed field ablation (PFA) for treating heart arrhythmias is being hailed as a breakthrough. However, as seasoned…
The recent court-approved injunction halting Edwards Lifesciences’ acquisition of JenaValve is more than just a hiccup in a single deal—it is a clear signal that regulators are sharpening their focus…
The European Medicines Agency’s decision to host a live Q&A clinic focused on Substance, Organisation, and Referential Management Services is more than a routine informational session—it’s a clear signal of…
The European Medicines Agency’s decision to host the Product Management Service (PMS) information day as a half-day online broadcast is emblematic of the ongoing tension between accessibility and depth in…
The upcoming Pharmacovigilance Risk Assessment Committee (PRAC) meeting scheduled for January 12-15, 2026 at the European Medicines Agency in Amsterdam represents more than just a routine regulatory checkpoint—it is a…
The European Medicines Agency’s decision to host a webinar on the new variations guidelines for marketing authorisation holders (human) is a predictable but underwhelming approach to what should be a…
The pervasive industry tendency to over-classify medical devices under higher risk categories is not just a benign over-cautiousness—it is a strategic failure that undermines the very purpose of risk-based regulation.…