INRatio maker Alere's financial results faltered in 2014

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%…

FDA APPROVED Rubber Stamp cut out on white background

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…

The Alere INRatio measures INR levels for those taking warfarin.

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…