Biocontrol Technology
This article was originally published in The Gray Sheet
Executive Summary
FDA will purchase one of the firm's Diasensor 1000 noninvasive blood glucose monitors, as the agency looks to "gain knowledge of the performance of such devices over their full range of performance," the company reports Feb. 9. The firm says it plans to "conduct a seminar to educate the FDA staff on the use and maintenance of this particular instrument so they can evaluate its performance characteristics and conduct laboratory research on noninvasive monitoring." Biocontrol has not yet resubmitted its 510(k) for the system since FDA's decision to withhold approval until further data on home use is collected