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For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.
The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.
The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.
The system is manufactured by Nova Biomedical.
For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.
The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.
The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.
The system is manufactured by Nova Biomedical.
For the first time, a blood glucose monitoring system has been cleared for use in critically ill hospitalized patients, the Food and Drug Administration announced on Sept. 24.
The device is the Nova StatStrip Glucose Hospital Meter System, which was cleared for use in 2006 for use in hospitals, but not in critically ill patients. It is “the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients,” according to the FDA statement.
The expanded use applies to indications using arterial or venous whole blood, from patients “in all areas of a hospital with various conditions, including: trauma, cancer, sepsis and infection; cardiac, kidney, neurological, obstetric, gynecological, gastroenterological, endocrine, and lung issues; and people recovering from general or cardiothoracic surgery,” the statement said.
The system is manufactured by Nova Biomedical.
