FDA 483 - Medical Metrics, Inc. - April 04, 2025

Medical Metrics, Inc. in Houston, TX, a medical device manufacturer, was cited for failing to report corrections or removals for its Class II medical device, SpineCAMP software, to the FDA. This oversight involved potential health risks related to discrepancies and errors in the software's analysis of X-ray images. The firm's own procedures for recalls and corrections were not followed regarding FDA reporting.