Spirometer/Oximeter Combo Cleared by FDA

A combination spirometer/pulse oximeter contained in a Type II PC card for use with a computer to diagnose and monitor respiratory diseases has been cleared by the U.S. Food and Drug Administration (FDA). According to the developer, it is the first such device to be cleared by the FDA.

Called the SpirOxCard, the card provides doctors with two point-of-care tests in one device that fits in a coat pocket and is compatible with most Windows handheld computers. Developed by QRS Diagnostic, LLC (Plymouth, MN, USA), the device's cost is low enough for use in worksite or home monitoring of patients with pulmonary diseases. The company states that is more advanced in each application than most single function devices.

Adaptable technologies that provide this degree of accuracy and affordability bring the goal of ambulatory disease management one step closer to reality, said Charles Jaffe, M.D., director of medical informatics at AstraZeneca Pharmaceuticals and chairman of the Clinical Information Systems of the American Medical Informatics Association.



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