FDA regulatory clearance for the Hospira Symbiq(TM) 3.13 infusion device


Intravenous products: Hospira, Inc. announced today that the company has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Symbiq(TM) 3.13 infusion device, the enhanced version of the company’s advanced infusion system platform. The clearance is one of the first to be granted through the new draft FDA regulatory guidance for 510(k) infusion pump submissions. Hospira is planning to start working with current customers to upgrade to the enhanced Symbiq device in the first quarter and expects to begin shipments to previously contracted customers in the second quarter.

“With the new Symbiq system, Hospira will provide clinicians and patients with one of the most technologically advanced and highest quality infusion pumps available,” said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. “We took a device that was designed to transform how hospitals deliver medications safely and reflect real-world clinician feedback, and then put the system through a rigorous development and regulatory process to increase its reliability.”

New Symbiq infusion pump innovations reflect how the device is used to administer medication at the patient’s bedside. Symbiq platform enhancements include:

  • more robust connectivity and wireless communication to enhance I.V. Clinical Integration,
  • improved software reliability, enabling more consistent performance across a range of clinical applications, and
  • updated software design that better supports optimal performance.

The Symbiq infusion system is a technologically advanced infusion device with clinician-friendly features designed to help improve workflow and decrease medication errors. For example, the Symbiq LCD touch screen — the largest infusion pump screen available — includes intuitive layouts and touch-activated buttons.

Click here for the full press release.

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