Pharmaceutical Business review

Biosafe granted European approval for anemia meter

European legislation requires manufacturers to display CE Marking on their products, packaging and accompanying literature. The CE Marking on a product allows it to be legally placed on the European market, assures its free movement within the member countries, and warranties that the product complies with relevant European health, safety and environmental protection legislations. In December 2004, the Food and Drug Administration granted approval for the sale of the Biosafe Anemia Meter in the US.

Anemia is a blood condition identified by a lower than normal number of red blood cells, usually measured by a decrease in the amount of hemoglobin. The disease can cause heavy menstrual periods, serious risk factors during pregnancy and older age, and is symptomatic of serious diseases such as chronic kidney disease, diabetes, heart disease, cancer, rheumatoid arthritis, inflammatory bowel disease, and HIV.

“Our goal is to bring products to market that benefit both the healthcare professional and the consumer. The Biosafe anemia meter provides a quick, easy and reliable way for physicians to test for anemia in their offices or for the consumer to screen for anemia at home,” said Biosafe’s chief science officer, Dr Jack Maggiore.