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…