Abbott Receives FDA Clearance to Market New Blood Glucose Monitor
March 23, 2006
Digg This! | Send to Newsvine | Add to del.icio.usNew Glucose Meter Requires Tiny Blood Sample, Provides Results in Just Five Seconds
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.
Posted by dlife at March 23, 2006 11:04 AM