AI Metrics LLC, Birmingham, Ala., a medical imaging startup focused on leveraging artificial intelligence to improve patient care, announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the company’s LSN (Liver Surface Nodularity) module. This first FDA clearance represents a significant milestone for AI Metrics, where researchers have been seeking new ways to use CT scans for virtual liver biopsy.
LSN’s proprietary algorithms process CT images of a patient’s liver to assess the nodules along the liver surface. This low-cost, low-risk, non-invasive procedure provides physicians with new information that may aid in the staging of CLD. Improved staging of CLD is vital in optimizing treatment and monitoring response in patients.
“We believe that LSN offers unique benefits and has the potential to become the standard of care for patients with CLD,” says Andrew Smith, MD, PhD, CEO and founder of AI Metrics LLC. “Standardizing a proven quantitative approach helps establish a common language with the treatment team, which ultimately helps patients.”
AI Metrics’ technology represents a tremendous cost savings opportunity for health systems by eliminating the need for patient fasting before liver assessment. Today, significant numbers of missed and rescheduled appointments occur when patients fail to adhere to pre-procedure fasting. In addition, LSN eliminates the need for high-cost surgical biopsy or specially adapted MRI or ultrasound equipment.
LSN is being distributed by Elm Grove, Wis.-based Imaging Biometrics LLC (IB), the makers of IB Neuro, which entered into a global distribution agreement with AI Metrics earlier this year.