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 ...
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 ...
Business Wire

Siemens Receives FDA Clearance of the Xprecia Stride™ Coagulation Analyzer

TARRYTOWN, N.Y.--(BUSINESS WIRE)--Siemens Healthineers has more than 30 years of central lab hemostasis leadership. Building on to its portfolio, the company announced today FDA 510(k) clearance for a ...
FierceBiotech

FDA holds meeting to weigh increased regulation of diagnostics for monitoring warfarin therapy

The FDA convened a workshop on point-of-care diagnostics for monitoring warfarin medication therapy, as it weighs increasing scrutiny of the devices. The agency said the device's inaccuracy is ...