PositiveID Corp. has submitted to the Food and Drug Administration a 510(k) pre-market notification application for its "iglucose" technology to better manage diabetes. FDA 510(k) clearance is necessary before the product can be commercially available.
The iglucose product enables the transmission of readings from a data-capable glucometer to a diabetes management Web portal where diabetics can gather and track their glucose levels and permit access to family members, caregivers and clinicians. The product eliminates the keeping of paper-based logbooks and helps increase self-management, according to the Delray Beach, Fla.-based vendor.
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