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

MARLBOROUGH, Mass.--(BUSINESS WIRE)---- $HOLX #Bacterial--Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company also announced that the assays obtained CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (IVDR). These highly sensitive molecular tests are designed to rapidly detect the most common bacterial patho ...