FDA clears CoaguSense home monitoring anticoagulation system
CoaguSense from Abbott has received FDA approval for its prothrombin time/international normalized ratio (PT/INR) monitoring system that detects blood clotting time for patients on anticoagulants.
According to the Fremont, Calif.-based company, the at-home, self-testing monitoring system should be used only for patients who are stabilized on warfarin (Coumadin, Bristol-Myers Squibb) and who have not previously been administered heparin or low-molecular weight heparin.
The company said that the monitoring solution uses a low-cost meter and disposable test strip and has been waived for use by the Clinical Laboratory Improvement Amendments for office use.
Abbott Point of Care and CoaguSense have an exclusive agreement to market and distribute the CoaguSense PT/INR monitoring system.
According to the Fremont, Calif.-based company, the at-home, self-testing monitoring system should be used only for patients who are stabilized on warfarin (Coumadin, Bristol-Myers Squibb) and who have not previously been administered heparin or low-molecular weight heparin.
The company said that the monitoring solution uses a low-cost meter and disposable test strip and has been waived for use by the Clinical Laboratory Improvement Amendments for office use.
Abbott Point of Care and CoaguSense have an exclusive agreement to market and distribute the CoaguSense PT/INR monitoring system.