BD Receives FDA 510(k) Clearance for Advanced Microbiology Solution

Original from: BD (Becton, Dickinson and Company) 

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for BD Phoenix™ M50 and BDXpert™ System on the BD Synapsys™ Informatics Solution, leveraging rapid identification (ID) and antimicrobial susceptibility testing (AST) algorithms to assist in the interpretation of complex diagnostic data to help ensure accurate and reliable diagnoses related to antimicrobial resistance (AMR).

BDXpert™ is an automated, rule-based system that analyzes ID and AST results from the BD Phoenix™ M50 Automated Microbiology System, further enhancing its capabilities. By integrating with the BD Synapsys™ Informatics Solution, this system aids laboratorians in addressing ongoing challenges related to understaffing, increased testing demands and evolving susceptibility testing standards by helping streamline data management, helping reduce the potential for errors, and providing the delivery of critical test results and accurate information to clinicians.

"Bacterial AMR contributes to nearly five million deaths each year around the world,” said Nikos Pavlidis, worldwide president, BD Diagnostic Solutions. “Rapid and precise ID/AST results lead to timely and appropriate treatment, helping reduce the spread of resistant infections and ensuring the right medication is used to combat the infection.”

The BDXpert™ system, when integrated with the cutting-edge technology of BD Synapsys™ and the BD Phoenix™ M50 automated system, offers a significant advancement in diagnostic microbiology, helping provide accuracy and efficiency to support clinical microbiology laboratories.

The integrated BDXpert™ system on BD Synapsys™ will be showcased at the upcoming European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress from April 11-15, in Vienna, Austria, booth C55.

Source: BD Receives FDA 510(k) Clearance for Advanced Microbiology Solution