Medical Equipment > Medical - General > Defibrillators > FDA Marketing Clearance For New Hospital Device
New Product: FDA Marketing Clearance For New Hospital Device
Posted: Wednesday, July 4, 2012 Location: Massachusetts, USA
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ZOLL Medical Corporation
LabX Member since November 2006.
For ZOLL, advancing resuscitation is the core of our existence. Our products and solutions encompass multiple facets of resuscitation and work as a system to help you improve survival rates.
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ZOLL RECEIVES FDA MARKETING CLEARANCE FOR NEW HOSPITAL DEVICEZOLL Medical Corporation (NASDAQ: ZOLL), a manufacturer of resuscitation devices and related software solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance for a new defibrillator designed for hospitals. As previously disclosed, ZOLL anticipates that it will launch the product in 2007.
According to Richard A. Packer, President and Chief Executive Officer of ZOLL, “Our Company has a history of bringing out highly differentiated products that can help caregivers establish new levels of patient care. From the original NTP-1000, which first brought pacing to the hospital market, to the market-leading M Series®, which established new size, weight, and usability standards for the industry, each generation of product has excited the marketplace and driven our business. Recently introduced products such as the AED Pro® with Real CPR Help™, the E Series™, and the AutoPulse® continue this trend. We expect a new hospital product to allow us to achieve a similar result.”
Mr. Packer also noted, “Launch of this new hospital product in 2007 will mark the culmination of ZOLL’s most aggressive product-line expansion since 1998. This is another major product from an R&D pipeline that has seen significant investment since 2004. These investments have yielded new products in all major defibrillator markets. Combined with other investments, ZOLL has built a resuscitation portfolio, and is now positioned as the only company offering a comprehensive set of products that improve multiple aspects of resuscitation. We believe that this portfolio will drive growth over the next few years, and help to address the worldwide problem of death from sudden cardiac arrest.”
About ZOLL Medical Corporation ZOLL Medical Corporation is committed to developing technologies that help advance the practice of resuscitation. With products for pacing, defibrillation, circulation, ventilation, and fluid resuscitation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims. ZOLL also designs and markets software that automates the documentation and management of both clinical and non-clinical information.
ZOLL markets and sells its products in more than 140 countries. The Company has direct operations, distributor networks, and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East, Asia, and Australia. For more information, visit www.zoll.com or contact using the form below.
Certain statements contained in this press release regarding matters that are not historical facts are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, ZOLL’s ability to compete in the resuscitation business; acceptance of its recently launched products; changes in regulations affecting the healthcare industry; global economic conditions; and those other factors discussed in the section entitled “Risk Factors” in ZOLL’s Quarterly Report on Form 10-Q, which was filed with the SEC on August 11, 2006.