EMA’s 2026 Product Management Service Day: A Missed Opportunity for Deeper Industry Engagement
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…
PRAC’s January 2026 Meeting: A Critical Juncture for Pharmacovigilance Strategy in Europe
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 Regulatory Risk-Classification Trap: Why Over-Compliance Is Killing Innovation and Efficiency
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’s $1.75 Billion Valuation Signals Shifting Dynamics in Medical Diagnostics Investment
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…
Why Medical Device PMS Must Break Free from Pharmaceutical Pharmacovigilance Paradigms
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…
2025’s Medtech Shakeup Sets the Stage for a Turbulent 2026
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…
Neurable’s $35M Raise Signals a Critical Inflection Point for Brain-Computer Interface Commercialization
Neurable’s recent $35 million Series A funding round is more than just a financial milestone—it represents a pivotal moment for the brain-computer interface (BCI) sector, especially as it inches closer…
EMA’s Cardiovascular Innovation Workshop: A Missed Opportunity for True Disruption
The European Medicines Agency’s upcoming multi-stakeholder workshop on cardiovascular medicines and medical devices, scheduled for July 2026, is positioned as a pivotal moment for fostering innovation within the EU. However,…
EMA’s Cardiovascular Innovation Workshop: A Missed Opportunity for Bold Industry Leadership
The upcoming EMA workshop on cardiovascular medicines and devices, scheduled for July 2026, positions itself as a platform for fostering innovation within the EU. However, from an industry standpoint, the…
CTIS Sponsor Training: A Necessary Step, But Are We Ready for the Real Challenges?
The European Medicines Agency’s announcement of the Clinical Trials Information System (CTIS) sponsor end user training program, scheduled for March 2026, is a critical milestone in the ongoing effort to…