BD
(NYSE: BDX)
announced today that the FDA granted 510(k) clearance for its updated Alaris infusion system.
Shares of BDX closed out Friday evening priced at $264.84 each. They ticked up significantly after market close on the back of the Alaris news, rising 5.9% to $280.40 apiece.
Clearance enables both remediation and a return to full commercial operations for the previously maligned infusion system. It covers updated hardware features for the point-of-care unit (PCU), large-volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules.
The updated clearance also covers a new software version with enhanced cybersecurity, plus interoperability features. These 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, chair, 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.
What led to the updated BD Alaris clearance?
Remediation, resumed commercial activity and updated cybersecurity features mark major steps forward for the BD Alaris system.
In early 2020, the company initiated an FDA Class I recall for the infusion pumps. The recall centered around multiple system errors, software errors, and use-related errors. BD cut its financial outlook for that year after it enacted a hold of new shipments of Alaris pumps. The company applied for a new FDA clearance for the pumps in April 2021. It started a remediation effort in July 2021.
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