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Baxter (BAX) Granted US FDA 510(k) Clearance of Novum IQ Syringe Infusion Pump

August 31, 2022 9:03 AM EDT

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Baxter International Inc. (NYSE: BAX), a leader in innovative technology for medication delivery, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Novum IQ syringe infusion pump (SYR) with Dose IQ Safety Software, representing Baxter’s latest developments for infusion therapy. The Novum IQ SYR has the capability to fully integrate with hospital electronic medical records (EMRs) through Baxter’s IQ Enterprise Connectivity Suite.

Syringe infusion pumps are typically used to precisely deliver small amounts of fluid at low rates, often in pediatric, neonatal or anesthesia care settings. The Novum IQ SYR delivers a technologically integrated user experience with enhanced safety features, advanced connectivity, configurable anesthesia care settings and a robust portfolio of sets designed to help deliver optimum accuracy. Its user interface incorporates features including colored visual banners that clearly identify enteral delivery, a backlit keypad and guided syringe loading.

“We are thrilled to bring a new syringe infusion pump to the market that represents the next generation of Baxter’s intelligent infusion ecosystem,” said Heather Knight, president, Medication Delivery, Acute Therapies, Clinical Nutrition, Latin America and Canada. “Together, the Novum IQ syringe infusion pump, Dose IQ Safety Software and IQ Enterprise Connectivity Suite advance the interoperability and data insights needed to help prevent harm and personalize therapy for patients, including neonates and other fragile patients.”

Protecting More Infusions with Advanced Technologies

Advancing the safety and efficiency of medication delivery and management is critical, as data continues to show the harmful burden of errors on patient safety.1,2 The Novum IQ SYR utilizes intuitive technologies built to help reduce infusion errors and was designed to meet rigorous FDA guidance for infusion devices, including cybersecurity.

The Novum IQ SYR features Baxter’s Dose IQ Safety Software, a web-based, customizable drug library and dose error reduction system that supports clinicians and hospitals by:

  • Helping ensure pumps are up to date with the latest drug and dose information through centralized access to drug library files
  • Incorporating titration error prevention technology to provide additional safety measures for infusions
  • Optimizing information technology infrastructure and accessibility
  • Offering flexibility to scale as hospital systems and technologies evolve

In addition to fully integrating the Novum IQ SYR with hospital EMRs, Baxter’s IQ Enterprise Connectivity Suite:

  • Enables over-the-air operating system upgrades to all Novum IQ SYRs connected to a hospital’s network
  • Allows option to enable auto-programming and auto-documentation of infusion data through full bi-directional integration with EMRs
  • Delivers near real-time infusion data and streamlined infusion reports
  • Provides clear visualizations of infusion data across a hospital system, allowing efficient identification of safety and process issues at every level of care
  • Offers option to implement tagless asset tracking that shows infusion pump location and status throughout the hospital, helping to save time and optimize resources

Baxter’s Novum IQ platform, which currently includes the Novum IQ SYR, Dose IQ Safety Software and IQ Enterprise Connectivity Suite, was intentionally designed to be forward-looking, as Baxter plans to expand the platform through continued product development and additional regulatory submissions. Another key part of the platform, the Novum IQ large volume pump (LVP), is currently available in Canada. Baxter’s application for 510(k) clearance for the Novum IQ LVP in the U.S. remains pending. Subject to receipt of all necessary approvals, Baxter expects to introduce the Novum IQ platform in markets around the world to continue delivering a strong and streamlined experience for customers.

For more information on the Novum IQ SYR, please visit Baxter.com.



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