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Tuesday, Jul 16, 2024

ICU Medical Touts FDA OK for Smart IV Pump

ICU Medical Inc. wants hospitals to question the equipment of rival pump makers.

“Is your IV smart pump smart enough?” ICU says on its website.

“Despite nearly two decades of innovations that have helped improve patient safety—from dose-error reduction software (DERS) to IV-EHR interoperability—too many IV smart pumps on the market today still leave patient safety risks unaddressed.”

The San Clemente-based supplier of infusion therapy-related medical equipment, one of Orange County’s most valuable publicly traded medical device makers with a $3.5 billion valuation as of last week (Nasdaq: ICUI), on Aug. 29 said it’s received domestic regulatory approval for a new delivery system that will be its roadmap for “best-of-breed IV pumps.”

The Food and Drug Administration on Aug. 29 gave 510(k) clearance for its “Plum Duo infusion pump with LifeShield infusion software.”

Both will be available to U.S. customers in early 2024.

ICU is a provider of infusion systems, infusion consumables and high-value critical care products used in hospital, alternate sites and home care settings. About 238 of its 15,000 employees work in San Clemente.

Plum Duo

The Plum Duo pump is the newest addition to ICU Medical’s portfolio of infusion devices to deliver medications to patients.

The product features a 10-inch color touch screen with an intuitive user interface and two channels capable of delivering up to four compatible IV medications.

The company says LifeShield is a cloud-based software suite that provides advanced new tools for comprehensive drug library management.

It enables clinicians the ability to access, process and quickly share information across an entire health system.

“Receiving FDA clearance for the Plum Duo pump and LifeShield software is the first step in realizing ICU Medical’s long-term vision of bringing customers best-of-breed devices with a shared platform and user experience,” Dan Woolson, corporate vice president and general manager of ICU Medical Infusion Systems, said in a statement.

Profit Forecast Lowered

ICU has struggled in the past two years following a $1.9 billion acquisition in early 2022 of the Smiths Medical business, a unit of London-based Smiths Group PLC.

The acquisition of Smiths, which makes syringe and ambulatory infusion devices, vascular access, and vital care products, didn’t go as smoothly as anticipated due to supply chain and other issues, the company reported 15 months ago.

Overall, ICU shares are down about 40% since the Smiths acquisition. Shares are down some 11% in 2023.

The previous supply chain problems have been resolved, the company reported Aug. 7 during a conference call with investors to discuss second-quarter results.

The company’s second-quarter sales declined 2.1% to $549.3 million. Analysts on average are expecting about $2.25 billion this year, which is about flat from a year ago.

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Sonia Chung
Sonia Chung
Sonia Chung joined the Orange County Business Journal in 2021 as their Marketing Creative Director. In her role she creates all visual content as it relates to the marketing needs for the sales and events teams. Her responsibilities include the creation of marketing materials for six annual corporate events, weekly print advertisements, sales flyers in correspondence to the editorial calendar, social media graphics, PowerPoint presentation decks, e-blasts, and maintains the online presence for Orange County Business Journal’s corporate events.

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