Baxter Announces U.S. FDA Clearance of Novum IQ Large Volume Infusion Pump and Dose IQ Safety Software, Advancing Connected and Intelligent Infusion Therapy

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DEERFIELD, Ill. - 2024-04-01

Baxter International Inc. (NYSE:BAX), an innovative leader in infusion therapies and technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Novum IQ large volume infusion pump (LVP) with Dose IQ Safety Software. Adding LVP modality to the Novum IQ Infusion Platform – which includes Baxter’s syringe infusion pump (SYR) with Dose IQ Safety Software, powered by the IQ Enterprise Connectivity Suite – enables clinicians to utilize a single, integrated system across a variety of patient care settings. Offering the Novum IQ LVP in the U.S. demonstrates Baxter’s commitment to continued innovation in advancing infusion therapy.

Heather Knight, executive vice president and group president, Medical Products and Therapies at Baxter, highlighted the customer-centric approach of the Novum IQ platform, emphasizing its role in helping to enhance care delivery. “Our goal, always, is to bring increased efficiency, safety and opportunity for informed decision-making to our customers, clinicians and the patients they serve,” Knight commented. “The Novum IQ platform represents a meaningful shift in how connected and intelligent infusion therapy can impact the way clinicians provide care. Offering Novum IQ large volume and syringe infusion pumps unlocks the potential of advanced, intuitive technologies that customers seek to meet their needs.”

Enhancing Patient Care Efficiencies with Advanced Connected Solutions

Health systems have experienced new and increased challenges related to clinician turnover, burnout and staffing shortages[i] in addition to existing priorities focused on reducing cost and improving patient outcomes. The Novum IQ Infusion Platform integrates user experience across its LVP and SYR pumps and helps to reduce the burden of non-critical tasks so that nurses, pharmacists and other clinicians can spend more time focused on patient care. Highlights of the platform include:

• Novum IQ LVP and Novum IQ SYR infusion pumps, which share a common user interface designed to accomplish association between a patient, medication and pump through a digital on-screen barcode. The pumps’ integrated experience also streamlines the training that clinicians need and helps reduce the cognitive burden associated with understanding how to properly operate multiple, disparate pump platforms.
• Dose IQ Safety Software, which features a web-based, customizable drug library and dose error reduction system. Dose IQ supports clinicians and hospitals by helping ensure pumps are up to date with the latest, facility-specific drug and dosage parameters and information through centralized access to current drug library files. In addition, Dose IQ includes exclusive titration error prevention technology designed to provide additional safety measures.
• IQ Enterprise Connectivity Suite, a scalable all-in-one server, integration engine and software application platform, designed to simplify infusion system connectivity for the Novum IQ Infusion Platform. The IQ Enterprise Suite enables:
  • Full bi-directional electronic medical record (EMR) interoperability with auto-programming and auto-documentation capabilities.
  • Enhanced Continuous Quality Improvement (CQI) reports that can provide on-demand and actionable graphical views of infusion data at the bedside.
  • Over-the-air software updates, which could help save clinicians time and enhance efficiency for biomedical engineers, who do not need to remove pumps from the nursing floor for manual software and firmware updates.
• Cybersecurity rigor, with Dose IQ Safety Software and IQ Enterprise Connectivity Suite both certified to the UL 2900 Series of Standards.

Based on clinical setting and patient need, hospitals may need and benefit from having access to both LVP and SYR pumps. Baxter’s Novum IQ LVP supports the administration of high-volume infusions at faster rates, while Novum IQ SYR supports the delivery of small, precise amounts of fluid at lower rates, often in pediatric, neonatal or anesthesia care settings.

The Novum IQ LVP and Novum IQ SYR are available to order in the U.S. Baxter expects to expand the platform in the future through continued product development and additional regulatory submissions.

For more information on the Novum IQ LVP, please visit www.NovumIQ.com.

About Baxter

Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X/Twitter, LinkedIn and Facebook.

Novum IQ LVP Indications for Use

The Novum IQ LVP is intended for use on adults and pediatrics subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood and blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural. The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition through the following clinically accepted routes of administration: intravenous and arterial. The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user. The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities. The Novum IQ LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors. The Novum IQ LVP is intended to be used by trained healthcare professionals.
 

Novum IQ Syringe Pump Indications for Use

The Novum IQ syringe pump is intended to be used for the controlled administration of fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition. The Novum IQ syringe pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral, and subcutaneous. The Novum IQ syringe pump is intended to be used in conjunction with legally marketed and compatible administration sets, syringes, and medications provided by the user. The Novum IQ syringe pump is suitable for patient care in hospitals and outpatient health care facilities. The Novum IQ syringe pump is intended for use on adults, pediatrics and neonates. The Novum IQ syringe pump is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors. The Novum IQ syringe pump is intended to be used by trained healthcare professionals.

Dose IQ Safety Software for Novum IQ LVP and Syringe Pump Indications for Use

Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support the controlled administration of fluids. Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps. Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter’s approved compatible syringes, for the Novum IQ Syringe Pump. Dose IQ Safety Software is intended to be used by licensed pharmacists. Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.

Rx only. For safe and proper use of the products mentioned herein, please refer to the appropriate Operators Manual.
 

This release includes forward-looking statements concerning Novum IQ, Dose IQ and IQ Enterprise, including potential benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks, including satisfactory clinical performance and obtaining and maintaining required regulatory approvals (including as a result of evolving regulatory requirements); breaches or failures of or vulnerabilities in the company's information technology systems or products, including by cyber-attack, data leakage, unauthorized access or theft; product quality, manufacturing or supply, or patient safety issues; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); actions of regulatory bodies and other governmental authorities; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements unless otherwise required by the federal securities laws.

Baxter, Novum IQ, Dose IQ and IQ Enterprise are registered trademarks of Baxter International Inc.