EU Experience: CE-Marked Diagnostic AI Article #8 in Medical ML for Ukrainian Doctors Series By Oleh Ivchenko | Researcher, ONPU | Stabilarity Hub | February 8, 2026 📋 Key Questions Addressed How does the European regulatory framework for medical AI differ from the US FDA approach? What is the impact of the EU AI Act…
US Experience: FDA-Approved AI Devices Article #7 in Medical ML for Ukrainian Doctors Series By Oleh Ivchenko | Researcher, ONPU | Stabilarity Hub | February 8, 2026 📋 Key Questions Addressed How has the US regulatory landscape shaped AI medical device development, and what does the current FDA approval landscape look like? What evidence exists…
Regulatory Landscape for Medical AI: FDA, CE Marking, and Ukrainian MHSU Article #6 in Medical ML for Ukrainian Doctors Series By Oleh Ivchenko | Researcher, ONPU | Stabilarity Hub | February 8, 2026 📋 Key Questions Addressed How do FDA, EU, and Ukrainian regulatory frameworks differ in their approach to AI-enabled medical devices? What are…