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FDA Clears Becton Dickinson Automated Microbiology Analysis Solution

NEW YORK – Becton Dickinson announced Wednesday that it has obtained 510(k) clearance from the US Food and Drug Administration for an integrated solution to assist in the interpretation of microbiology data. 

The cleared solution integrates BD Synapsys informatics with the BDXpert system's rule-based rapid identification and antimicrobial susceptibility testing results obtained from the BD Phoenix M50, Franklin Lakes, New Jersey-based BD said in a statement. It is intended to streamline data management, reduce the potential for errors, and deliver test results and information to clinicians. 

"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," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. 

The solution also addresses challenges that labs continue to face around understaffing, testing demand, and evolving susceptibility testing standards, BD said. 

In February, the firm announced it will spin off its Biosciences and Diagnostics Solutions business by the end of 2026.