High-quality image of a professional at the SIIM Annual Meeting, showcasing networking and educational opportunities in medical imaging and health IT.

Event Speaker

Yujan Shrestha, MD

Partner

Innolitics, LLC

Dr. Shrestha is a physician, software engineer, AI/ML expert, and regulatory consultant. He has been developing medical device software for 14 years. He has helped startups and Fortune 500 companies write medical grade software and secure regulatory clearance. He was born in Nepal, came to the states when he was 4, and learned to code BASIC when he was 8. He graduated with a BME degree from UT Austin and a MD degree from UT Houston. He is passionate about decreasing barriers to translating medical devices from the lab to the clinic for the benefit of patients and physicians alike.

Sessions

From Concept to Clinic:
A Real-World Guide to AI/ML SaMD

Presented by Yujan Shrestha, MD, Andrew D. Smith, <br>MD PhD in Radiology Jun 10, 2026 | 4:15 PM.

Developing AI and ML imaging solutions for clinical use requires careful planning, rigorous data practices, and a clear understanding of regulatory pathways. Many imaging informatics professionals, radiologists, and engineers have strong prototypes but struggle to navigate the transition to an FDA-cleared Software as a Medical Device (SaMD). Early decisions in dataset curation, annotation, documentation, and…

Event Speaker

Yujan Shrestha, MD

Partner

Innolitics, LLC

Sessions

From Concept to Clinic:
A Real-World Guide to AI/ML SaMD

Registration + Housing Now Open

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Event Speaker

Yujan Shrestha, MD

Partner

Innolitics, LLC

Sessions

From Concept to Clinic: A Real-World Guide to AI/ML SaMD

Registration + Housing Now Open

From Concept to Clinic:
A Real-World Guide to AI/ML SaMD