BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System
Prnewswire·2025-11-03 11:50

Core Insights - BD (Becton, Dickinson and Company) has received FDA 510(k) clearance and CE marking for its Enteric Bacterial Panel (EBP) and Enteric Bacterial Panel plus (EBP plus) for the BD COR™ System, enhancing diagnostic capabilities for gastrointestinal infections [1][2]. Group 1: Product Features and Benefits - The EBP and EBP plus utilize advanced Polymerase Chain Reaction (PCR) technology to test a wide range of gastrointestinal bacterial pathogens from a single stool swab, streamlining workflows for clinicians [1][2]. - The EBP plus is the only high-throughput, bacterial-only molecular panel that detects Enterotoxigenic Escherichia coli (ETEC) and associated toxins, improving patient management and reducing unnecessary antibiotic use [3]. - The BD COR™ System can automate nearly 1,650 tests and deliver up to 1,000 sample results in 24 hours, maximizing efficiency with minimal manual interaction [4]. Group 2: Market Context and Impact - Gastrointestinal infections lead to over 1.7 million deaths globally each year, with significant healthcare burdens in the U.S., including 179 million outpatient visits and 500,000 hospitalizations annually due to diarrhea [1]. - The introduction of these panels addresses the urgent need for rapid and accurate diagnostics, which is critical for improving patient outcomes and supporting antimicrobial stewardship [1][2]. Group 3: Company Overview - BD is one of the largest global medical technology companies, focused on advancing health through innovative technology and solutions that enhance clinical therapy and healthcare delivery [7][8]. - The company has a strong commitment to improving the safety and efficiency of healthcare processes, with a presence in virtually every country and partnerships aimed at addressing global health challenges [8].