FRANKLIN LAKES, N.J., July 21, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States.

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.

"The 510(k) clearance of the updated BD Alaris™ Infusion System has been the number one priority for our teams who have been steadfast in their efforts to achieve this milestone, consistent with our commitment to quality," said Tom Polen, chairman, CEO and president of BD. "We are deeply committed to ensuring clinicians can continue to rely on our market leading system to meet today's most critical infusion needs. The features and enhancements incorporated into the updated BD Alaris™ Infusion System and subject to this clearance reinforce our advancements in smart, connected care, which deliver greater benefit to clinicians and patients and help improve health care system efficiency through better care coordination and utilization of actionable information."

Extending BD's Decades-Long Legacy of Leadership in Infusion Innovation

Today's clearance further enhances BD leadership in the infusion pump market. The updated BD Alaris™ Infusion System will help empower hospitals and health systems to optimize their workflows and deliver a higher standard of care, which has never been more important than in today's health care environment of staffing shortages and resource constraints.

The BD Alaris™ Infusion System is the only system with a centralized user interface for up to four modules for all major types of infusions, including large volume pumps, syringe pumps, and PCA therapy with optional respiratory monitoring. Having one, comprehensive infusion system enables hospitals and health systems to easily scale their infusion needs across an entire integrated delivery network and provide interoperability with EMRs. With a common Point-of-Care Unit, one interface controls all modules, which is different from other pumps on the market that have non-modular architecture. The "one system" approach offers ease, simplicity and scalability.

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