INDIANAPOLIS, Oct. 1, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus ...

Roche Diagnostics announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the CoaguChek XS Pro system, a new point-of-care anticoagulation monitor with a ...

Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial ...

INDIANAPOLIS, Nov. 11 The U.S. Food and DrugAdministration has granted approval for the new Handheld Base Unit for theCoaguChek(R) XS Plus System, which provides connectivity between ...

Roche announced the launch of the CoaguChek XS mPOC app for use with the CoaguChek XS meter. The new app makes the Bluetooth-enabled PT/INR reporting offered by CoaguChek Patient Services even more ...

As Pharma giant Roche continues its dive into the digital health realm, it is releasing a new self-testing device for INR or blood coagulation levels, that can wirelessly connect to a smartphone app.

A voluntary recall of certain test strips made by Roche Diagnostics for use with its CoaguChek warfarin anticoagulation meters is now categorized as Class I, the US Food and Drug Administration has ...

Roche Diagnostics has recalled more than 1.1 million packages of its CoaguChek XS PT test strips, which are used for monitoring international normalized ratio (INR) in patients taking warfarin. The US ...

A new recall has been issued CoaguChek XS PT test strips, used to monitor international normalized ratio (INR) in patients taking warfarin, due to inaccurately high readings. Roche Diagnostics ...

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy INDIANAPOLIS, Oct. 1, 2012 ...