Evaluating only AiMedic’s profile at its peak — without knowing the outcome — the model ranked Unit economics as the #1 likely cause. Documented cause: Regulation.
Key Events Timeline
FOUNDING
FUNDING
MILESTONE
CRISIS
SHUTDOWN
Full Analysis
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Documented cause
AiMedic built AI-powered radiology image analysis tools for detecting early-stage lung cancer and cardiovascular abnormalities, with clinical validation studies showing 94% sensitivity. The platform was technically ready for commercial deployment in 2019. However, the EU Medical Device Regulation (MDR) 2017/745 transition required full clinical evidence packages and notified body review that extended the certification timeline from 18 months to 4+ years. The company burned through capital maintaining the team during the regulatory wait and could not raise a bridge round in the 2022 down market.
Lesson
“For EU medical AI, raise capital for a 5-year regulatory runway from day one. Any company that raises for 18 months of MDR certification is under-capitalized by design.”
Failure anatomy
Collapse type
Slow Death
🐌 LOW
Hype cycle
Trough
Moat type
Technology
Fatal mistake
EU Medical Device Regulation certification delayed commercialization by 3 years