Organon’s recent FDA approval to extend Nexplanon’s effective use from three to five years is a textbook example of how incremental regulatory wins can reshape market dynamics in the contraceptive…
The recent admission that deaths linked to a medical device were tied to off-label or investigational use should serve as a wake-up call for the healthcare marketing community. This is…
Guardant Health’s new multi-year strategic partnership with Merck (MSD) for companion diagnostics development is a textbook example of how diagnostic companies must align with pharmaceutical giants to remain relevant in…
The UK Dementia Research Institute’s (UK DRI) announcement of an international trial for a finger-prick blood test to diagnose Alzheimer’s marks a significant milestone in neurodegenerative disease diagnostics. From a…
The healthcare industry stands at a pivotal crossroads as AI-enabled tools like ChatGPT Health rapidly embed themselves into patient behavior. This is not a futuristic speculation; it is today’s reality.…
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 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 webinar on the new variations guidelines for marketing authorisation holders (human) is a predictable but underwhelming approach to what should be a…
KORU Medical’s recent 510(k) submission for the FreedomEDGE infusion system is hardly a surprise, but it does raise important questions about differentiation and market positioning in an increasingly saturated infusion…