Beckman Coulter received a warning letter from the FDA for marketing the “AccuTnI on the Access Immunoassay System” heart test without agency approval. The agency said the company was marketing the test for a heart-problems marker illegally because it had not received clearance to do so. The system is intended to detect the troponin I protein, a marker for heard ailments. The company announced in April removal of its AccutnI Troponin kits from its Unicel Dxl immunoassay system that lacked FDA approval. (Click here for more – a subscription may be required)
“FDA Warns Beckman Coulter On Marketing Of ‘AccuTnI’ Heart Test” – Wall Street Journal (7/6/10)
Medical device manufacturers facing many challenges: from the rising clout of group purchasing organizations (GPOs) to payment bundling and physicians' growing allegiance with hospitals in product price negotiations. Get all the answers now in new Medtech Insight's new 24-page Special Report: Medical Device Landscape: How regulatory changes and cost control measures are reshaping the industry. Available for purchase now!

