FDA clears BD’s advanced diagnostic system to combat antimicrobial resistance

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Key Takeaways

BD Phoenix M50 and BDXpert System received FDA 510(k) clearance, advancing antimicrobial resistance efforts with the BD Synapsys Informatics Solution.
The system uses advanced algorithms for rapid, accurate identification and antimicrobial susceptibility testing, ensuring proper bacterial infection treatment.
BDXpert automates data interpretation, streamlining workflows, reducing errors, and accelerating critical diagnostic information delivery to clinicians.
BD's innovation supports clinical microbiology labs facing increased testing volumes, workforce shortages, and evolving diagnostic standards.

The newly cleared system uses advanced identification and antimicrobial susceptibility testing algorithms to support the interpretation of complex microbiological data.

FDA clears BD's advanced diagnostic system: ©BD

BD (Becton, Dickinson and Co.) announced that the FDA has granted 510(k) clearance for the BD Phoenix M50 and BDXpert System on the BD Synapsys Informatics Solution, a key development in the fight against antimicrobial resistance.

The newly cleared system uses advanced identification (ID) and antimicrobial susceptibility testing (AST) algorithms to support the interpretation of complex microbiological data. The goal: deliver fast, accurate, and reliable diagnostic results that help ensure the proper treatment of bacterial infections and reduce the spread of resistant pathogens.

BDXpert is an automated, rule-based system that interprets ID and AST data generated by the BD Phoenix M50 Automated Microbiology System. When integrated with the BD Synapsys Informatics Solution, the platform supports laboratory professionals by streamlining workflows, reducing the potential for errors, and accelerating the delivery of critical diagnostic information to clinicians.

“Bacterial AMR contributes to nearly five million deaths each year around the world,” said Nikos Pavlidis, worldwide president of 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.”

BD’s latest innovation underscores its commitment to supporting clinical microbiology labs as they face mounting pressures from rising testing volumes, workforce shortages, and evolving diagnostic standards, according to the company.