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First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA hopes the clearance of Nova Biomedical’s Nova StatStrip blood glucose monitor for hospitalized patients will help alleviate fears that increased regulatory standards will restrict critically ill patients’ access to point-of-care glucose testing. But the clearance does not necessarily settle the agency’s long-term policy plans for hospital-use glucose meters.


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