AI/ML device companies need to prepare for intensified public scrutiny of their performance data. Small differences among subgroups ...

Last week I spoke at the Stanford Graduate School of Business about regulatory paths for AI/ML medtech devices and common pitfalls that...

Your investors are excited about the revenue potential in Europe, not to mention what an EU CE mark can do for your rest-of-world...

Laboratory-developed test (LDT) manufacturers are accustomed to not having to deal with the FDA, who has historically exercised...

Due to looming deadlines and mounting political pressure, medical device manufacturers in the US and the EU will need additional...