Kris Huang, Physician Engineer

Kris Huang, MD PhD

PHYSICIAN ENGINEER

Joined: October 7, 2024

Summary

In under two years at Innolitics I helped six AI/ML imaging devices reach FDA 510(k) submission, after clearing my own Class II radiation therapy device in 2024. I earned my PhD in biomedical engineering and my MD at Wake Forest, trained in radiation oncology at the University of Miami, spent five years as an assistant professor of radiation oncology at the University of Cincinnati, and then built and cleared my own deformable image registration software as a startup CTO, publishing the method in Physics in Medicine & Biology in 2019. At Innolitics I work the seam between clinic, code, and FDA: study design, standalone and MRMC performance testing, pre-submissions, FDA orientation meetings, and deficiency responses for imaging AI in radiology, oncology, and dentistry. I spoke at RSNA 2025 on taking a device from bench to bedside.

Skills

• Oncology • Medical imaging • AI • Regulatory clearance • UI/UX

Bio

Kris Huang, MD, PhD, is a physician and biomedical engineer with extensive experience in medical device software development and regulatory affairs. He has led the development and FDA 510(k) submission of a Class II medical device, and has expertise in medical image processing, machine learning, and software design. Dr. Huang is a skilled communicator who can bridge the gap between medical professionals, software engineering teams, and regulatory bodies.

Hobbies

Legos, video games, tinkering

Articles by Kris Huang