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BD (BDX) Receives FDA Nod to Address Critical Infusion Needs

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Becton, Dickinson and Company (BDX - Free Report) , popularly known as BD, recently received the FDA’s 510(k) clearance for its updated BD Alaris Infusion System. This is expected to enable both remediation and a return to full commercial operations for the comprehensive infusion system in the United States.

The latest FDA clearance is expected to significantly solidify its foothold in the infusion system market in the United States and strengthen its Medical segment.

Few Words on the Infusion System

The latest clearance covers updated hardware features for Point-of-Care Unit, large-volume pumps and syringe pumps, among others. It also covers a new BD Alaris Infusion System software version with enhanced cybersecurity and interoperability features, enabling smart and connected care with the most widely used electronic medical record (EMR) systems.

The BD Alaris Infusion System can also feed data to the BD HealthSight platform for enterprise medication management. With this platform, health systems can view infusion status in real-time and access an intuitive knowledge portal with actionable information related to clinician trends and drug and fluid libraries.

Significance of the Approval

Per BD, the updated BD Alaris Infusion System will empower hospitals and health systems to optimize their workflows and deliver a higher standard of care despite staffing shortages and resource constraints. BD also believes that a comprehensive infusion system will enable hospitals and health systems to easily scale their infusion needs across an entire integrated delivery network and provide interoperability with EMRs.

BD’s management believes that the FDA’s 510(k) comprehensive clearance of the updated BD Alaris Infusion System will likely meet the critical infusion needs. Management also added that the features and enhancements incorporated into the updated BD Alaris Infusion System are expected to reinforce BD’s advancements in smart, connected care to benefit clinicians and patients and help improve healthcare system efficiency via better care coordination and utilization of actionable information.

FY23 Outlook Updated

BD expects to begin shipping devices and recognizing revenues in fiscal 2024 and does not expect any material incremental revenue contribution from the BD Alaris Infusion System for the remainder of fiscal 2023. 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.

BD will provide additional details during its fiscal third-quarter earnings call on Aug 3, 2023.

Industry Prospects

Per a report by Precedence Research, the global infusion pump market was estimated to be $13 billion in 2022 and is anticipated to reach $24.6 billion by 2030 at a CAGR of 8.3%. Factors like the increased incidences of chronic diseases, the growing elderly population and the rising surge for ambulatory infusion pumps are likely to drive the market.

Given the market potential, the latest regulatory approval is expected to significantly strengthen BD’s business worldwide.

Notable Developments in Medical Arm

In May, BD announced expanded customer availability of an all-in-one pre-filled flush syringe with an integrated disinfection unit, BD PosiFlush SafeScrub. It has been designed to reinforce compliance with infection prevention guidelines and simplify nursing workflow.

The same month, BD announced its second-quarter fiscal 2023 results, wherein it recorded solid top-line and bottom-line results and improvements in the overall base revenues. The BD Medical segment also reported a solid uptick in worldwide revenues from the year-ago quarter, both on a reported basis and at constant exchange rate. Per management, this upside resulted from strong double-digit growth in Medication Management Solutions and Pharmaceutical Systems business units.

Price Performance

Shares of BD have gained 9.2% in the past year compared with the industry’s 17.8% rise and the S&P 500's 14.4% growth.

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Zacks Rank & Other Key Picks

Currently, BD carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the broader medical space are AmerisourceBergen Corporation , HealthEquity, Inc. (HQY - Free Report) and Boston Scientific Corporation (BSX - Free Report) .

AmerisourceBergen, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 8.9%. ABC’s earnings surpassed estimates in all the trailing four quarters, with an average surprise of 3.1%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AmerisourceBergen has gained 33.6% compared with the industry’s 17.8% rise over the past year.

HealthEquity, sporting a Zacks Rank #1 at present, has an estimated long-term growth rate of 22%. HQY’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 9.1%.

HealthEquity has gained 6.5% against the industry’s 11.5% decline over the past year.

Boston Scientific, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 11.5%. BSX’s earnings surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 1.9%.

Boston Scientific has gained 39.9% compared with the industry’s 4.7% rise over the past year.


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