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 anticoagulation monitor with a ...
This notification supplements previous Urgent Medical Device Correction (UMDC) communications initially issued by Roche Diagnostics on September 12, 2018 and updated on October 17, 2018. Roche ...
Secure online application developed in conjunction with Voluntis helps simplify patient management for physicians and reporting of test results for patients who self-test PT/INR INDIANAPOLIS, Nov. 8, ...
COAGUCHEK XS PLUS SYSTEM anticoagulation monitor by Roche Roche announced that it has been granted CLIA-waived status by the FDA for the CoaguChek XS Plus system, a point-of-care anticoagulation ...
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 ...
The CoaguChek XS system is recommended for self‑monitoring coagulation status in adults and children on long‑term vitamin K antagonist therapy who have atrial fibrillation or heart valve disease if: ...
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