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NaviSure News
Medical device regulatory trends and in-depth analysis
AI/ML Devices: The Global Transparency Push
AI/ML device companies need to prepare for intensified public scrutiny of their performance data. Small differences among subgroups ...
Adam Odeh
Jul 30, 20244 min read
Stanford talk: The path to market for AI/ML medtech
Last week I spoke at the Stanford Graduate School of Business about regulatory paths for AI/ML medtech devices and common pitfalls that...
Adam Odeh
Feb 29, 20241 min read
EU Market Entry for Medical Devices: Regulatory Realities
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...
Adam Odeh
Feb 14, 20245 min read
FDA Targets Lab-developed Tests: A Regulatory Shift
Laboratory-developed test (LDT) manufacturers are accustomed to not having to deal with the FDA, who has historically exercised...
Adam Odeh
Feb 8, 20243 min read
5 bold regulatory predictions for medical devices in 2024
Due to looming deadlines and mounting political pressure, medical device manufacturers in the US and the EU will need additional...
Adam Odeh
Jan 30, 20244 min read
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