Alere Inc. sees gross profits plunge over $100 million in 2014 In its March 2015 10k filing with the Securities and Exchange Commission (SEC), Alere, the maker of the INRatio PT/INR monitor system, revealed its gross profits in 2014 decreased $100.5 million compared to the previous year. The dive in annual gross profits represents an 8%…
Alere INRatio users suffering severe bleeding events after relying on erroneous PT/INR reading Patients taking blood-thinning drugs like warfarin need to be aware of their PT/INR levels to prevent serious injuries or death. These incidents may occur because of severe bleeding events brought on by inappropriate warfarin doses. Many warfarin users rely on the Alere…
The Alere INRatio PT/INR monitor system is used by patients prescribed to the anticoagulant medication (blood thinner) warfarin. It is an electronic device powered by battery or power supply which tracks the PT/INR levels in a patient’s blood. The Alere INRatio PT/INR monitor system works by inserting a test strip into the device then applying…
FDA’s 510(k) program allows medical device makers to skip clinical trials Under a little-known FDA process, medical device makers selling products similar to previously-approved devices are able to forego the burdensome and costly traditional approval process. The FDA’s Premarket Notification program allows medical device makers like Alere to sell their products to consumers more rapidly, but critics say…
Prothrombin Time (PT) is a test that measures how long it takes the liquid portion of blood (plasma) to clot. PT is an important measure to diagnose unexplained bleeding, especially when a patient is taking anticoagulants (blood thinners) like warfarin. PT is measured in seconds and usually provided as an International Normalized Ratio (INR). For a healthy individual not…