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 ...

Globally, how many patients are estimated to be taking Warfarin and what are the main reasons the drug is prescribed? There are roughly 10 million people worldwide taking Warfarin, accounting for more ...

INDIANAPOLIS, March 30 Roche Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care ...

INDIANAPOLIS, July 26 Roche Diagnostics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CoaguChek® XS Pro system, a new point-of-care ...

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 ...

FREMONT, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- CoaguSense, Inc., a subsidiary of i-SENS (KOSDAQ:099190), today announced that it has received approval for the sale of the Coag-Sense ® PT/INR ...

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 ...

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 ...