Drug news

FDA announced FDA 510(k) clearance for Xprecia Stride Coagulation Analyzer- Siemens HealthCare Diagnostics

Read time: 1 mins

Last updated:17th Oct 2016

Published:10th Oct 2016

Source: Pharmawand

Siemens Healthcare Diagnostics announced FDA 510(k) clearance for a hand-held portable coagulation analyzer. The Xprecia Stride Coagulation Analyzer delivers fast, reliable Prothrombin Time International Normalized Ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin, a vitamin K antagonist.

Comment; It is estimated about 10 million patients globally are taking Warfarin. Patients are prescribed the drug for a variety of reasons, including the treatment of blood clots in the veins or certain heart conditions which increase the likelihood of a potentially life-threatening clot forming. Patients on Warfarin require frequent testing of the clotting tendency of their blood. PT-INR testing allows physicians to adjust patient doses for diet and lifestyle changes.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Related news and insights

Drug news

European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older.- Vertex.

Vertex Pharmaceuticals announced that the European Commission has granted approval for the label expansion of Kayydeco (ivacaftor) for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

1 mins

Drug news

Novavax is prepared to deliver protein-based non-mRNA JN.1 COVID-19 vaccine in line with WHO recommendation this fall.

Novavax is Prepared to Deliver Protein-based Non-mRNA JN.1 COVID-19 Vaccine in Line with WHO Recommendation this Fall

1 min

Drug news

CHMP positive for Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.- Idorsia Ltd.

Idorsia Ltd announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), adopted a positive opinion for the use of Jeraygo (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.

1 min

See all news