Why Becton Dickinson Stock Is Trading Higher Today?

The FDA approved BD's (Becton, Dickinson, and Company) BDX BD Alaris Infusion System with 510(k) clearance, which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the U.S.

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 and interoperability features that enable smart, connected care with the most widely used electronic medical record (EMR) systems.

The company says the BD Alaris Infusion System is the only system with a centralized user interface for up to four modules for all major infusions, including large-volume pumps, syringe pumps, and PCA therapy with optional respiratory monitoring. 

Also Read: Becton Dickinson Banks $540M With Surgical Unit Sale, 360 Employees To Join Steris.

In 2020, the company initiated an FDA Class I recall for the infusion pumps. The recall centered around multiple system, software, and use-related errors. 

The company applied for a new FDA clearance for the pumps in April 2021. It started a remediation effort in July 2021.

It expects a return to full commercial operations and sales in its Infusion business over time, with remediation or replacement of devices in the field taking priority. 

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 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, excluding the impact of COVID-only testing and foreign currency.  

Price Action: BDX shares are up 6.48% at $282 during the premarket session on the last check Monday.