Healthtech Pigeon Why healthtech regulation is sexy
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Aug 10, 2025 Benedikt von Thüngen from Sanome shares insights on the groundbreaking CE certification for their infection detection software. He discusses the challenges of navigating regulatory frameworks in healthtech and highlights the critical role of data in improving early infection detection. The conversation shifts to the ethical responsibilities of health tech manufacturers, particularly about accountability. They also touch on the impact of AI tools in mental health, underlining the need for balanced regulation to ensure user safety.
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Certification Proves Safety And Trust
- Benedikt von Thüngen says CE marking forces vast evidence that proves a tool works and is safe.
- This evidence lets hospitals and clinicians trust the product and its claims.
Real-Time Data Unlocks Personalized Models
- Benedikt explains they spent years securing real-world, real-time data feeds to build clinically relevant AI.
- With live data, models can support thousands of granular clinical decisions rather than static retrospective claims.
Use Silent-Mode With Post-Market Follow Up
- Build your model on retrospective data and deploy it in silent mode to calibrate performance in real clinics.
- Then run post-market clinical follow-up to prove real-world safety while allowing faster market entry.