Abbott Receives FDA Clearance For The First Automated Blood Glucose Monitor
Abbott Laboratories, MediSense Products, announced today that it has received U.S. food and Drug Administration marketing clearance for Sof-Tact™, a new diabetes management system. Sof-Tact is the first automated glucose monitor to offer lancing, blood collection and glucose testing with a single press of a button
In addition to the convenience of automated testing, the system offers users an easy and virtually painless method of obtaining blood samples. As an alternative to the traditional fingerstick sampling method, the device allows samples to be drawn from less sensitive areas of the body such as the forearm or upper arm. The device also employs new strip technology, which requires less blood.
"Sof-Tact gives people with diabetes an excellent alternative to painful fingerstick testing," said Mike Collins, vice president and general manager, MediSense Products. "By integrating blood sampling and testing, the system eliminates many user-generated errors and, therefore, provides a level of consistency and accuracy unmatched by other manual methodologies."
Sof-Tact provides a fully automated test at the press of a button. The meter uses a unique vacuum mechanism that holds the skin in place while an integrated apparatus lances the skin. The blood is automatically transferred to a low-volume biosensor strip, and a blood glucose test result is delivered in 20 seconds.
MediSense's Sof-Tact is the newest blood glucose-monitoring product to be launched by Abbott. The system follows the recent launch of Precision Xtra™, an advanced diabetes management system that measures both blood glucose and blood ketone levels.
"Abbott is committed to bringing innovative technologies to market to assist people with diabetes," said Tom Brown, senior vice president, Diagnostic Operations, Abbott Laboratories. "We've demonstrated this commitment with a series of new products that focus on improved disease management, patient comfort and convenience."
The Sof-Tact system, which will be called Soft-Sense™ in Europe, will be distributed worldwide through Abbott's international sales and marketing organizations. The system will be commercialized through standard retail, mail order and direct-to-consumer channels, including new e-commerce initiatives.
Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 58,000 people and markets its products in more than 130 countries. In 1999, the company's sales and net earnings were $13.2 billion and $2.4 billion respectively, with diluted earnings per share of $1.57.
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