Medical imaging startup gets FDA clearance for Liver Surface Nodularity software

Reviewed by Emily Henderson, B.Sc.Dec 5 2020

AI Metrics, LLC, a medical imaging startup focused on leveraging artificial intelligence to improve patient care, has received United States Food and Drug Administration 510(k) clearance and CE mark clearance for the company's Liver Surface Nodularity software.

The first FDA clearance represents a significant milestone for the early-stage startup, which launched from the University of Alabama at Birmingham last year. The company operates from the Innovation Depot and also recently announced the completion of a $1.7 million seed round of investment secured from members of the local Alabama Capital Network.

AI Metrics was founded by Andrew D. Smith, M.D., Ph.D., vice chair of Clinical Research in the UAB Department of Radiology. Smith seeks to improve accuracy, efficiency and standardization in radiologic imaging and reporting by incorporating cutting-edge technology.

The startup's proprietary algorithms process computerized tomography -- also known as CT or CAT scan -- images of a patient's liver to measure the nodularity or bumpiness along the liver surface. The amount of liver surface nodularity is directly related to the severity of chronic liver disease. The LSN aids in the treatment of patients with chronic liver disease.

Liver Surface Nodularity software provides a practical, low-cost, non-invasive method to monitor patients with chronic liver disease. LSN standardizes the approach, helps establish a common language with the treatment team and ultimately helps patients."

Andrew D. Smith, M.D., Ph.D., Vice Chair of Clinical Research, UAB Department of Radiology

AI Metrics technology represents a tremendous cost-saving opportunity for health systems, as the software solution applies to liver images from all CT scanners in an institution and requires no additional hardware. For patients, a CT scan is quick and easy and does not require patient fasting prior to the scan. The Liver Surface Nodularity software eliminates the need for a high-cost surgical biopsy or specially adapted MRI or ultrasound equipment.

510(k) premarket notification is a submission made to the FDA to establish that a medical device is as safe and effective as, and is substantially equivalent to, an already legally marketed device. This 510(k) clearance allows AI Metrics to begin marketing the Liver Surface Nodularity software in the United States. Similarly, the CE mark clearance indicates that the product meets European Union standards for health and safety and allows AI Metrics to market the Liver Surface Nodularity software in the European Economic Area.

Liver Surface Nodularity software is being distributed by Imaging Biometrics, LLC, based in Elm Grove, Wisconsin, which entered into a global distribution agreement with AI Metrics earlier this year.