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healthtechbuilders · Jul 15, 2026

Clinical AI on Hard Mode

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Julie Yoo · healthtechbuilders

A masterclass by Suchi Saria about building clinical AI on hard mode: achieving FDA breakthrough designation and de novo clearance (”we treat FDA not as the ceiling, but as the floor”), earning CMS NTAP reimbursement, getting clinicians to trust your tech and make high-stakes decisions based on its outputs, validating and generalizing an AI model to work at population scale, and focusing on the use cases that represent the biggest drivers of mortality and utilization.

Her company

Bayesian Health is an elegant example of clinical rigor meets utility meets financial sustainability for health systems.

Read the original on healthtechbuilders.substack.com

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