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.…
PathoCare Holdings’ recent announcement of a $1.75 billion valuation via a private third-party tender offer is more than just a financial milestone—it’s a clear indicator of evolving investor confidence in…
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…
The collaboration between Intelligent Bio Solutions (INBS) and Syrma Johari to scale up production of the intelligent fingerprint drug screening reader is a textbook example of how strategic partnerships can…
Curasight’s initiation of the Phase I clinical trial for its uTREAT diagnostic platform targeting high-grade gliomas marks a noteworthy milestone in neuro-oncology diagnostics. However, as healthcare marketing professionals, we must…
Peter Collins stepping in as CEO of CellBxHealth and immediately shifting away from the entrenched one-stop-shop research model signals a crucial, if overdue, recalibration. The original model, while ambitious, often…
The persistent conflation of medical device and IVD Post-Market Surveillance (PMS) with pharmaceutical pharmacovigilance (PV) is a fundamental misunderstanding that continues to plague regulatory compliance and quality management in our…
ZOLL’s recent unveiling of the next-generation LifeVest wearable cardioverter defibrillator (WCD) in the US is positioned as a forward leap in cardiac care technology. However, healthcare marketing professionals should critically…
The medical device industry is at a pivotal crossroads as we look toward 2026, and the seismic shifts in 2025 are more than just fleeting headlines—they are harbingers of a…