Instrumentation Laboratory landed 510(k) approval from the Food & Drug Administration for its ACL AcuStar hemostasis testing system, clearing the way for the immunoassay analyzer to hit the market.
IL said it will begin selling the device, which is a fully-automated hemostasis immunoassay analyzer that uses chemiluminescent markers, in Europe — and it will have some extra euros to spend on marketing.
A French court yesterday awarded IL roughly $2.6 million in damages (that’s about €2 million) after ruling that Diagnostica Stago infringed the French counterparts of two of its European patents for the detection of thrombosis.
The Bedford-based device maker also said the federal watchdog agency cleared its HemosIL AcuStar D-Dimer assay for the diagnosis of venous thromboembolism.