Hospira Receives FDA Clearance for Symbiq™ 3.13 Infusion Pump
-- One of the first general infusion pumps to receive clearance under new infusion pump 510(k) regulatory guidance --
HOSPIRA LOGO Like the name Hospira, the logo is unique, differentiating and contemporary. The arc highlights the word
LAKE FOREST, Ill., March 8, 2012 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, announced today that the company has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Symbiq™ 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. This unique touch-screen technology also enables hospitals to add future applications or "apps."
With Hospira MedNet™ safety software built into the device, Symbiq was the first general infusion system designed to provide additional medication-error protection by requiring users to select a drug library entry from the safety software for all drug delivery programs. Due to its highly sophisticated technology, Symbiq is one of the first devices to achieve I.V. Clinical Integration of infusion pumps with electronic health record systems, which can help decrease the number of steps and time required to program the infusion pump and significantly enhance nursing workflow and productivity.
The Symbiq device's FDA clearance is not expected to impact Hospira's 2012 financial projections, which were issued on Feb. 14, 2012.
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at www.hospira.com.
Private Securities Litigation Reform Act of 1995 -- A Caution Concerning
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the U.S. Food and Drug Administration (FDA) 510(k) clearance of the Symbiq infusion system and statements regarding expected shipments dates. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, regulatory, quality, legal, technological and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
SOURCE Hospira, Inc.
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