A blood test made by a Malvern company that can help diagnose Alzheimer's disease, a form of dementia affecting more than 7 million Americans, has been cleared by the U.S. Food and Drug Administration ...

The US Food and Drug Administration has given clearance to another blood test to help assess Alzheimer’s disease and other ...

Diagnostics company bioMerieux (PARIS:BIM) has received 510(k) clearance from the U.S. Food and Drug Administration for a test to detect and screen for methicillin-resistant staphylococcus, more ...

BD Diagnostics, a segment of Becton, Dickinson and Co., has announced it received FDA clearance to market a new MRSA test, according to a news release. BD received clearance for the BD MAX MRSA ...

A blood test that can predict whether pregnant women are at risk of developing preeclampsia, one of the world's leading causes of maternal death and disability, recently received clearance from the ...

Alere Inc. has announced that its Alere™ Reader has received 510(k) marketing clearance from the U.S. Food and Drug Administration. The Alere Reader was released in Europe and select Asian markets in ...

The FDA has granted 510(k) market clearance to the OneDraw A1C Test system, which monitors HbA1c levels in individuals with diabetes for long-term glucose control. The Food and Drug Administration ...

Personal Genome Diagnostics reached a key milestone in its effort to make genomic profiling of cancer available to patients and oncologists at the local level — and it’s the first to do so for a ...

Hologic’s FDA clearance for its Panther Fusion GI Bacterial and Expanded Bacterial Assays represents the company’s entry into the gastroenteritis test market.