FDA Grants Expanded Clearance for Nova Biomedical’s Glucose Meter

Nova Biomedical received 510(k) clearance for its StatStrip glucose hospital meter system, the first finger-stick capillary testing meter for critically ill patients with and without diabetes.

The device can now be used with capillary, venous and arterial specimens from all patients. It can be used for point-of-care testing to measure and correct for abnormal hematocrit, the percentage of blood by volume that is made up of red blood cells.

The new clearance eliminates the need for hospitals using StatStrip to define “critically ill” patients for testing purposes.