FDA still have not approved a single high sensitive troponin assay, despite Roche and abbot having them on the market in Europe for several years.
Here is Abbots clinical trial. Been going for over 1 year now. https://clinicaltrials.gov/ct2/show/NCT02060760
Philips will have a long road ahead.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm230118.htm
FDA still have not approved a single high sensitive troponin...
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