Automated Glucose Monitor Cleared by FDA

An automated glucose monitor that offers lancing, blood collection, and glucose testing with a single press of a button has been cleared by the U.S. Food and Drug Administration (USDA). An alternative to traditional fingerstick sampling, the device allows blood 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.

Called Sof-Tact (Soft-Sense in Europe), 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 29 seconds. The new device is the product of Abbott Laboratories, MediSense Products (Bedford, MA, USA). Abbott will distribute the device worldwide through its international sales and marketing organizations.

"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,” said Mike Collins, vice president and general manager, MediSense Products.



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