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BD Expands BD MAX™ System Menu with New IVDR-Certified VIASURE Assays in Partnership with Certest Biotec
Prnewswire· 2025-12-15 21:40
FRANKLIN LAKES, N.J., Dec. 15, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the expansion of its respiratory and sexually transmitted infection (STI) diagnostics offerings in Europe following In Vitro Diagnostic Medical Device Regulation (IVDR) certification of two VIASURE assays developed by Certest Biotec for use on the BD MAXâ"¢ System. The addition of these new assays to the BD MAXâ"¢ System portfolio enables clinical l ...
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].