Becton Dickinson receives FDA 510k clearance for updated BD Alaris system

BD announced that the updated BD Alaris Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration, 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, large volume pumps, syringe pumps, patient-controlled analgesia 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 systems. “The 510(k) clearance of the updated BD Alaris(TM) 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.”