Tzu-Kuei Shen

Visionary CTO and technology leader with nearly 20 years of experience translating cutting-edge AI and computer vision into globally compliant, highly scalable commercial products. Currently CTO & Vice President at V5med Inc., I specialize in bridging the gap between advanced algorithms, edge-to-cloud infrastructure, and rigorous international regulations.Throughout my career, I have successfully driven AI transformation across two of the most demanding industries: Semiconductor Manufacturing and Healthcare. I am passionate about building resilient engineering teams and creating software architectures that solve real-world industry pain points.🚀 Key Highlights:Transforming Healthcare AI (SaMD): Led the development of a lung cancer screening CADe system, securing both Taiwan TFDA (2022) and US FDA (2025) clearances following a large-scale US clinical trial. Our clinical outcomes have been published in the highly prestigious JACR.Global Ecosystem Integration: Architected a Cloud-to-Edge Hybrid PACS AI platform with successful integrations into global EHR giants, ensuring seamless clinical workflows.Deep Tech & Edge Computing: Ph.D. in Electrical and Control Engineering (NCTU) with deep-rooted expertise in DSP SoC, edge AI, and multiple-sensor telematics.Strong IP Portfolio: Holds 20+ patents across the US, Japan, and Taiwan, building a robust technical moat for business expansion.Core Competencies: Artificial Intelligence | Software as a Medical Device (SaMD) | Edge-to-Cloud Architecture | FDA 510(k) Strategy | Technical Leadership | Product Scalability