TCTMD

FDA: ROCKET AF Results Not Affected by Faulty INR Testing in Warfarin Arm

The US Food and Drug Administration (FDA) has concluded that inaccurate results from the point-of-care device used to measure international normalized ratio (INR) values in warfarin-treated patients ...
National Institute for Health and Care Excellence

Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

The assessment consisted of a systematic review of the evidence on test performance and clinical‑effectiveness data for the CoaguChek XS system, the INRatio2 PT/INR monitor, the ProTime ...
The American Journal of Managed Care

STABLE Results: Warfarin Home Monitoring Achieves Excellent INR Control

Real-world retrospective analysis of over 29,000 patients performing INR home monitoring for warfarin therapy shows excellent time in therapeutic range. Point-of-care, home international normalized ...
TCTMD

FDA Tackles Regulatory, Scientific Issues With Point-of-Care Coagulation Monitoring Devices

As issues related to potential problems with the device used to monitor warfarin therapy in the ROCKET AF trial continue to be discussed, the US Food and Drug Administration (FDA) is taking a deeper ...
Medscape

Alere to Withdraw Anticoagulation Monitors From US Market

Alere Inc will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 prothrombin time/international normalized ratio (PT/INR) monitoring system because of the potential for the ...
National Institute for Health and Care Excellence

Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

The Diagnostics Advisory Committee reviewed the evidence available on the clinical and cost effectiveness of self‑monitoring coagulometers for self‑testing or self‑managing coagulation status in ...