MedTech innovators are driven by one goal: getting life-changing technologies to patients faster. Meanwhile, regulatory professionals are committed to ensuring every device meets the highest standards of safety and compliance. But too often, these two worlds struggle to speak the same language.
The result? Long learning curves, wasted engineering time, costly delays, and far too many innovations that never reach patients who need them.
SE.ai bridges this critical gap.
We combine deep regulatory expertise with purpose-built artificial intelligence to streamline the FDA submission process—starting with 510(k). With SE.ai, innovators can stay focused on breakthroughs, while regulatory compliance unfolds in parallel, guiding them step-by-step toward approval.
SE.ai: Where innovation and regulatory excellence finally move at the same speed.
Leon Zheng, Co-founder and Chief Executive Officer at SE.ai
Having founded and exited on several medical device startups in the United States and abroad, Leon has successfully navigated the FDA’s 510(k) approval process multiple times. He holds sixteen international patents for his technologies and has been in the medical device field for over 25 years. Leon has personally designed, received approval for, and manufactured devices ranging from infrared temperature sensors to complex radiosurgery treatment devices which have saved the lives of over 30,000 patients worldwide. He has a strong passion for artificial intelligence and its potential to boost innovation for medtech engineers. Leon brings his hands-on experience to SE.ai as a heartfelt voice of the customer and is integral in ensuring the efficiency and usability of our solutions.
Wenjie Du, Co-founder and Chief Technology Officer at SE.ai
Wenjie holds a Master of Applied Science in Electrical and Computer Engineering from Concordia University, Montreal, Canada. His research majors in time-series AI and involves machine learning on electronic health records. He founded and leads PyPOTS, an open-science research organization dedicated to advancing AI for time series analysis, delivering scientific software that has been applied by researchers from over 200 universities/companies and achieved over 1 million downloads. He contributes his solid expertise in software development and distinct insights in artificial intelligence to build innovative solutions for SE.ai.
Shu Li (Joseph), Co-founder and Chief Operating Officer at SE.ai
Having spent over 26 years at the intersection of strategy, technology, and e-commerce, Joseph has shaped the trajectories of some of the world’s most influential companies. As Head of Strategy, SEC member and Group VP at JD.com, he steered corporate and retail strategy for one of China’s largest e-commerce giants, architecting strategic innovations in AI, robotaxi, and instant retail, while forging landmark partnerships with Walmart and Tencent. Previously, as a Partner at Bain & Company and a Managing Director at BCG, he co-led the Greater China TMT practice, advising industry titans including Tencent, Baidu, Alibaba, and vivo. His thought leadership has been featured in Harvard Business Review and MIT Sloan Management Review, and he has shared his insights on CNBC, Singapore Money FM. Joseph holds an MBA from The Wharton School and a Master of Economics from the University of International Business and Economics in China. As COO of SE.ai, he translates this deep strategic expertise into operational excellence, bridging the gap between visionary innovation and disciplined execution to ensure our solutions are not only powerful but also scalable, efficient, and built to deliver real-world impact.
SE.ai 