Hologic Receives FDA Clearance and CE Mark for Automated Molecular Tests to Detect Common Causes of Infectious Gastroenteritis

Core Insights - Hologic, Inc. has received 510(k) clearance from the U.S. FDA for its Panther Fusion® Gastrointestinal Bacterial and Expanded Bacterial Assays [1] - The assays have also obtained CE marking in the European Union under the In Vitro Diagnostic Regulation (IVDR) [1] - These molecular tests are designed to rapidly detect the most common bacterial pathogens [1]