View printer-friendly version

<< Back

FDA Alternate Site Clearance Offers BD Blood Glucose Meter Users More Convenience

Palm testing for BD products deemed equivalent to finger testing BD blood glucose monitoring products now offer combination of more convenience and more comfort FRANKLIN LAKES, N.J., Nov. 4 /PRNewswire-FirstCall/ -- BD (Becton, Dickinson and Company) (NYSE: BDX) today announced that it recently received clearance from the U.S. Food and Drug Administration (FDA) that will allow people using the BD Logic(TM) and Paradigm Link(R) blood glucose meters to use alternate site testing (off-finger) when checking their blood glucose levels. "This is great news for people with diabetes," said Bill Marshall, President, Diabetes Care, BD Medical, "Coupled with the BD Ultra-Fine(TM) 33 gauge Lancets -- the thinnest lancet on the market -- this clearance by the FDA equating palm testing with fingertip testing for users of the BD Logic(TM) and Paradigm Link(R) provides people a more convenient and comfortable 'best in class' approach to checking their blood glucose levels." The scope of the FDA 510(k) clearance for BD includes palm and forearm testing for the BD Logic(TM) and Paradigm Link(R) blood glucose meters. While other meters on the market have been cleared for alternate site testing, this specific clearance makes palm testing the equivalent to fingertip testing for our specific blood glucose-monitoring systems. BD is now one of a very small group of companies that may claim that palm testing is equivalent to fingertip testing for blood glucose monitoring systems. According to Dr. Barry Ginsberg, MD, PhD and Vice President of Medical Affairs for Diabetes Care, BD Medical, "This clearance means that patients can now test on their palm when using BD Logic(TM) and Paradigm Link(R) meters and know that the values are accurate. The values will tell the patient what is happening now, not 10-30 minutes ago, as often found with arm testing. Patients can now safely test on the palm even after eating, exercising, taking insulin or when their blood glucose is low." "Before I started using BD Logic(TM), I did not check my blood sugar regularly -- it was painful and difficult. The BD meter is easy to use and requires a small amount of blood. And the BD Lancets are very thin, so they do not hurt at all. Now, I am checking my blood sugar at least four times a day; my diabetes is in much better control and I feel good," says Carlos Lasiloo, a participant in the BD Diabetes Makeover, a registered nurse and an administrator in the Indian Health Service. "I also like the fact that the BD Logic(TM) meter now lets me test from alternate sites, like my palm, which I cannot do with (all) other meters." About BD Logic(TM) and Paradigm Link(R): * BD Logic(TM) Blood Glucose Monitor The BD Logic(TM) Blood Glucose Monitor produces accurate results in just 5 seconds, requires one of the smallest blood volumes (0.3ul), and uses the thinnest lancet available-BD Ultra-Fine(TM) 33 Lancets (33 gauge) -- for 50% less pain. * Paradigm Link(R) Blood Glucose Monitor Paradigm(R) insulin pumps (model 512, 515, 712 and 715) and the Paradigm Link(R) Blood Glucose Monitor are the only pumps and meters that communicate automatically using wireless technology that both saves time and effort, as well as reduces potential errors associated with manually entering meter values into an insulin pump. Manufactured by BD specifically for use with Paradigm(R) insulin pumps (model 512, 515, 712 and 715), the Paradigm Link(R) Blood Glucose Monitor provides fast results in just 5 seconds, requires one of the smallest blood volumes (0.3ul), and uses the thinnest lancet available -- BD Ultra-Fine(TM) 33 Lancets (33 gauge)-for 50% less pain. About BD BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. For the fiscal year ended September 30, 2004, BD reported revenues of $4.935 billion. This press release may contain certain forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future revenues, products and income, or events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to: competitive factors; pricing and market share pressures; changes in interest or foreign currency exchange rates; changes in BD's sales volume and product mix; BD's ability to achieve its cost savings objectives; difficulties inherent in product development and delays in product introductions; changes in regional, national or foreign economic conditions; increases in energy costs; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; uncertainties of litigation; and changes in healthcare or other governmental regulation; issuance of new or revised accounting standards, as well as other factors discussed in this press release and in BD's filings with the Securities and Exchange Commission. We do not intend to update any forward-looking statements. SOURCE BD (Becton, Dickinson and Company) /CONTACT: Michael Marinello of BD, +1-201-847-7437, Michael_Marinello@bd.com/ /Web site: http://www.bd.com / (BDX)

Powered by Thomson