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…
The EMA’s AI Workshop: A Critical Juncture for Healthcare Innovation or Regulatory Overreach?
The upcoming HMA/EMA multi-stakeholder workshop on artificial intelligence scheduled for November 2025 signals a pivotal moment for the European healthcare ecosystem. While the initiative to bring together diverse voices in…