The Problem
Drs. Rothenberg and Dr. Andrew Smith at UAB identified a need to address the global cardiovascular disease (CVD) burden using AI for opportunistic screening during routine imaging. Given limited primary care access and late diagnoses, they proposed AI-based image processing to detect cardiomegaly, an indicator of underlying CVD. Standard care doesn't assess cardiomegaly due to its cumbersome measurement, making it an ideal candidate for AI. This approach, focusing on early detection via cardiothoracic ratio measurement, aims to improve health outcomes and reduce CVD progression.
What We Did
Innolitics did the entire project end to end—everything from algorithm R&D, software engineering, regulatory clearance, and clinical study design and coordinated the study execution.
- Trained the algorithm and performed multiple rounds of R&D at UAB
- Developed an AI/ML algorithm from data and annotations collected at UAB using tools such as MONAI
- Transformed the research-grade algorithm into an FDA-compliant, deployable solution
- Consulted the UAB research team to collect the appropriate data necessary to substantiate an 510(k) submission
- Conducted an FDA presubmission meeting to validate study design before execution
- Created and submitted the 510(k)
- Handled all FDA cybersecurity concerns
- Handled all FDA communications including hold letter response strategy and defense
Timeline
March 6 2023: FDA Presubmission Meeting
June 28 2023: Algorithm development done
July 26 2023: Clinical Performance Study Completed
August 28 2023: 510(k) Submitted
November 3 2023: FDA Hold Letter received
February 28 2024: 510(k) Cleared
About Steven
Dr. Steven Rothenberg is an Assistant Professor in the Cardiopulmonary Imaging Section at the University of Alabama at Birmingham (UAB) Department of Radiology and a pioneer in radiology innovation. He holds a Bachelor's in Physics from the University of Maryland and a medical degree from George Washington University. During his residency in Diagnostic Radiology, Dr. Rothenberg co-founded EnvoyAI—the first radiology AI marketplace—which was later acquired by TeraRecon.
Dr. Rothenberg's research focuses on imaging informatics, population health screening, and non-pharmacologic pain interventions. Recognized for his entrepreneurial spirit with accolades such as the Department or Radiology Light Bulb Award and UAB Harbert Institute for Innovation and Entrepreneurship Most Prolific Inventor, Dr. Rothenberg continues to push the boundaries of innovation in radiology and healthcare technology.
