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Abbott Receives FDA 510K Clearance to Market FreeStyle(R) Freedom(TM) Blood Glucose Monitoring System

Posted on: Monday, 13 March 2006, 09:01 CST

ALAMEDA, Calif., March 13 /PRNewswire-FirstCall/ -- Abbott Diabetes Care announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FreeStyle(R) Freedom(TM) blood glucose monitoring system for consumer use.

FreeStyle Freedom offers virtually pain-free testing because it measures glucose levels using a very small blood sample size (0.3 micro liter), the smallest sample size required of any blood glucose monitoring product on the market. FreeStyle Freedom provides results in just five seconds and features a large, high contrast display, making it easy to read, and easy to hold. The new meter also allows people with diabetes to test on less sensitive parts of the body such as the forearm, thigh and palm. FreeStyle blood glucose meters offer the most approved alternative testing sites of any glucose monitoring system available.

"To successfully manage diabetes, patients must monitor their blood glucose levels frequently," said Sherwyn L. Schwartz, M.D., founder and chief executive officer of the Diabetes & Glandular Disease Clinic in San Antonio, TX. "In clinical trials, we found FreeStyle Freedom to be very accurate, and the small sample size and rapid test time associated with this new blood glucose meter may make testing less painful and could ultimately encourage those with diabetes to test more often," Dr. Schwartz added.

FreeStyle Freedom uses a technology exclusive to all FreeStyle meters based on coulometric measurement. This unique, patented, electrochemical technology measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. Coulometric technology has already been used by people with diabetes worldwide in more than 2 billion blood glucose tests using FreeStyle blood glucose strips.

"FreeStyle Freedom expands Abbott's product line of innovative, easy-to- use and less painful blood glucose testing devices to meet the diverse needs of people with diabetes," said Ed Fiorentino, president of Abbott Diabetes Care.

FreeStyle Freedom blood glucose monitoring systems will be available in April, 2006.

About Abbott Diabetes Care

Abbott Diabetes Care, based in Alameda, Calif., is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help patients better manage their diabetes. Abbott Diabetes Care is committed to developing products to reduce the discomfort and inconvenience of blood glucose monitoring and introducing systems that are easier to use, require smaller blood samples and provide faster results.

Abbott Diabetes Care manufactures and markets several leading-edge glucose monitoring systems and test strips in the United States for use in both home and hospital settings; leading brands include FreeStyle(R), FreeStyle(R) Flash(TM) and Precision Xtra.(TM) Additional information about Abbott Diabetes Care may be found at http://www.abbottdiabetescare.com/ .

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ .

Abbott

CONTACT: Media, Tama Antonia Donaldson, +1-510-749-5449, or FinancialCommunity, John Thomas, +1-847-938-2655, both of Abbott

Web site: http://www.abbottdiabetescare.com/http://www.abbott.com/

Company News On-Call: http://www.prnewswire.com/comp/110328.html

Source: PRNewswire-FirstCall

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