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BD receives FDA 510(k) clearance for updated BD Alaris Infusion System

Press releases may be edited for formatting or style | July 25, 2023 Infusion Pumps

BD has been preparing for the updated clearance and return to full commercial operations by investing in the proper operational capacity and functional capabilities to provide customers with the best experience possible. This includes investments to increase manufacturing capacity, strengthen supply chains and increase supplier redundancy to help the company meet its remediation obligations and continue to reliably supply infusion products to customers. BD also retained its infusion implementation and service teams while products were on ship-hold to ensure support for its customers during the pandemic and enable seamless execution upon clearance.

BD has created a website dedicated to supporting customers who have questions about the updated 510(k) clearance or remediation at bd.com/explore-bd-alaris.

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Updated Business Outlook

As previously disclosed, the company expects a return to full commercial operations and sales in its Infusion business to happen over time, with remediation or replacement of devices in the field taking first priority. While the company is well positioned to engage with customers and execute as quickly as possible, the lead time to shipment and installation is also dependent on customer readiness. Therefore, BD expects to begin shipping devices and recognizing revenue in FY24 and does not expect any material incremental revenue contribution from the BD Alaris™ Infusion System for the remainder of FY23. The company expects that the initial investments to return its Infusion business to full commercial operations will be absorbed within its previously announced FY23 guidance range.

The BD Alaris™ Infusion System's clearance and return to full business operations increase the company's confidence in achieving its previously disclosed BD2025 financial targets of 5.5%+ revenue growth and double-digit adjusted EPS growth, both of which exclude the impact of COVID-only testing and foreign currency.

BD will provide additional commentary during the company's previously announced third quarter earnings call being held Thursday, Aug. 3 at 8 a.m. ET.


About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 77,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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