Roche has launched a home self-test Bluetooth device for patients to measure blood clotting status, with results sent straight to the doctor. It will be available in all countries accepting the CE ...

DARESBURY, UNITED KINGDOM--(Marketwired - May 12, 2016) - Bio-AMD, Inc. and Bio-AMD Holdings Ltd., our majority owned medical devices subsidiary (together "Bio-AMD", "We" or the "Company") (OTCQB: ...

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 ...

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 ...

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 ...

My doctor has approved use of the Phillips Self Testing PT/INR machine. Medicare will pay 80 percent of the test strip cost. Does TRICARE cover PT/INR self testing? Thank you. Anna G. Via the Internet ...

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 ...

Alere announced a voluntary Class 1 recall of the Alere INRatio2 PT/INR Professional Test Strips due to significantly different test results between the Alere INRatio2 PT/INR Professional Test Strips ...

Patients taking the oral anticoagulant drug warfarin (Coumadin) or being given heparin injections and their in-office and home healthcare teams should check the brand of their PT/INR test strips and ...

The market for home healthcare devices is growing at a steady clip, and Roche ($RHHBY) is wise to the trend. The Swiss diagnostics giant is launching its PT/INR home ...