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Share Name | Share Symbol | Market | Type |
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Abitare In Spa | BIT:ABT | Italy | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.19 | 4.51% | 4.40 | 4.20 | 4.40 | 4.40 | 4.27 | 4.27 | 28,976 | 17:00:00 |
The U.S. Food and Drug Administration wants blood-sugar monitoring devices used by diabetics to be more accurate, according to its commissioner.
The FDA has asked an international standards-setting body to toughen accuracy requirements for home-glucose monitors. The agency says it believes the current standard is too lax because it allows inaccuracies of up to 20% in the devices. Diabetics use the devices to determine whether their blood-sugar levels are unsafe and they require medication.
"If we're unable to convince the international community to tighten the accuracy standards for glucose meters," the FDA may pursue "higher performance standards ourselves," FDA Commissioner Margaret Hamburg said in a speech at a conference of regulatory-affairs professionals in Philadelphia on Wednesday.
Hamburg said the devices have generally been effective in managing diabetes since their introduction in the 1970s. But she asserted there haven't been any significant improvements in accuracy over the past decade because manufacturers are content to meet the international standard, set by the International Organization for Standardization, or ISO, a non-governmental organization based in Geneva.
Johnson & Johnson (JNJ), Abbott Laboratories (ABT) and other companies make the devices. J&J doesn't break out the products' sales, but they are part of its diabetes-care franchise, which had $2.5 billion in sales last year. Abbott's diabetes-care unit had $1.35 billion in sales last year.
Dave Detmers, spokesman for J&J unit LifeScan, said Thursday that the company is working with other manufacturers, regulators and doctors to review the accuracy standards for glucose monitors and determine whether changes are needed. LifeScan's OneTouch products have exceeded the ISO criteria for the past seven years, he said. If standards are changed, LifeScan would work to ensure its products meet or exceed them, he added.
Abbott also is working as part of the international group reviewing accuracy standards for blood-glucose meters, said spokesman Greg Miley. He said the company will continue to meet current and future regulatory standards that may be put into place for the devices.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
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