21.07.2023 23:09:51
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Becton, Dickinson's Alaris Infusion System Gets FDA's 510(k) Clearance
(RTTNews) - Shares of Becton, Dickinson and Company (BDX) gained 5% in the extended trading session on Friday after the medical technology company announced that the updated BD Alaris Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
This clearance enables both remediation and a return to full commercial operations for the infusion system.
This clearance covers updated hardware features for Point-of-Care Unit (PCU), large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules. It also covers a new BD Alaris Infusion System software version with enhanced cybersecurity, along with interoperability features that enable smart, connected care with the most widely used electronic medical record (EMR) systems.
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