Yujan Shrestha is a partner and seasoned technical leader with 12 years of experience turning AI research into FDA-cleared medical devices, combining MD and biomedical engineering training with deep software engineering chops. He co-founded and served as CTO of Innolitics, running white-glove programs that have delivered multiple rapid 510(k) and De Novo clearances and even pathways that shortened time-to-market to months. Yujan regularly functions as fractional C-suite technical, medical, and regulatory officer—bridging ML architecture, clinical validation, and pragmatic regulatory strategy to minimize burden while preserving clinical rigor. His hands-on background ranges from low-level data acquisition and DICOM handling to TensorFlow-based imaging pipelines and QMS implementation, so he speaks fluently to engineers, clinicians, and regulators. Based in Denver, he focuses on mid-sized medtech companies ready to commercialize AI SaMD, and he’s known for leveraging established FDA relationships and vendor networks to accelerate real-world impact.
12 years of coding experience
13 years of employment as a software developer
Bachelor's Degree Biomedical/Medical Engineering, Bachelor's Degree Biomedical/Medical Engineering at The University of Texas at Austin
Doctor of Medicine (M.D.) Medicine, Doctor of Medicine (M.D.) Medicine at UTHealth Houston
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