Key things

  • The FDA has granted 501(k) clearance to Becton Dickinson’s updated BD Alaris infusion system.
  • The system faced several appeals, and CEO Tom Polen said the update was targeting them.
  • Becton Dickinson shares rose to their highest level since 2020 on the news.

Becton Dickinson (BDX) was the best-performing stock in the S&P 500 after the US Food and Drug Administration (FDA) an approved permit for an updated infusion system from a medical device manufacturer.

Becton Dickinson said the FDA gave 501(k) permit for its BD Alaris infusion system, which enables hospitals and healthcare systems to run up to four modules for all major infusion types, including high-volume pumps, syringe pumps and patient-controlled analgesia (PCA) with optional respiratory monitoring.

The FDA’s decision came after BD Alaris faced several appeals. CEO Tom Polen said the new version “addresses all open downloads,” adding that it has “the latest hardware, a new software version, and important cybersecurity updates.”

He explained that the company will now work to bring the updated BD Alaris to customers, with an initial focus on correcting or replacing those currently in use in the US.

Becton Dickinson shares rose 5.7% in intraday trading to their highest level in three years following the news.

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