Yujan Shrestha, MD. Engineer, Physician, AI/ML Expert, Entrepreneur, and Trusted Advisor

Hi. I am Yujan Shrestha, MD. I am a physician, engineer, AI/ML practitioner, business owner, entrepreneur, and expert at FDA clearances for AI/ML medical devices. I was born in Nepal, came to the US at age 4, learned to code at 8 years old, have 12 years of experience in medical device software, and have helped over 50 AI/ML enabled medical devices go from idea inception to FDA clearance to revenue creation. I speak many languages and wear many hats so I can help bridge the gaps between engineering, clinical, regulatory, marketing and business stakeholders. Using my proven process, my clients get to FDA clearance in months, not years.

I earned my Bachelor's degree in Biomedical Engineering from the University of Texas at Austin before completing my M.D. at the University of Texas Health Science Center at Houston. This dual background has allowed me to bridge clinical medicine with advanced technology, driving meaningful innovation in healthcare.

In 2012, I co-founded Innolitics, a specialized medical software development and regulatory consulting firm dedicated to helping companies build, test, and gain FDA approval for groundbreaking Software as a Medical Device (SaMD). Under my leadership Innolitics has successfully guided more than 50 medical devices through FDA clearance, significantly streamlining the regulatory process to deliver approvals in as little as three months. I've personally overseen multiple 510(k) submissions, navigated complex regulatory pathways, and proactively managed interactions with FDA reviewers.

Throughout my career, I have led and contributed to numerous successful AI medical device projects. Notable among these are AI Metrics—a radiology AI platform for oncology imaging cleared by the FDA in 2020—and BodyCheck's CT Cardiomegaly software, an AI-driven tool for quantifying heart enlargement on CT scans, which we cleared in 2024. My efforts have consistently accelerated product timelines, minimized regulatory setbacks, and conserved valuable startup resources.

I recently gave a talk about AI software as a medical device at RSNA.

As a thought leader in medical AI, I frequently share insights through conference presentations, FDA advisory panels, webinars, and media interviews. I have presented at renowned events such as the Radiological Society of North America (RSNA) annual meetings, offering guidance on FDA clearance strategies for AI/ML-enabled medical devices. Additionally, my expertise has been featured in industry podcasts and webinars, where I've discussed practical approaches to regulatory compliance and risk management for innovative healthcare technologies.

Beyond regulatory strategy and software engineering, I actively contribute to shaping industry best practices. At FDA's Digital Health Advisory Committee in 2024, I proposed innovative strategies for post-market surveillance of generative AI medical devices, emphasizing the importance of ongoing monitoring using synthetic data and automated validation to ensure patient safety without hindering innovation.

My peers and clients recognize me for my ability to translate complex regulatory requirements into actionable strategies. Testimonials highlight my team's effectiveness in rapidly navigating FDA clearances, with some projects achieving approvals years ahead of schedule and significantly under budget. Through ongoing collaboration with startups, established healthcare companies, and regulatory bodies, I remain deeply committed to advancing healthcare technology that improves patient outcomes and clinical workflows.

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Each day you are not on the market means hundreds of patients that could have benefited and thousands of dollars of lost revenue. Let me help accelerate your pathway to market.