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FDA approves first diabetes test

For the first time ever the FDA has granted marketing approval to equipment for diagnosing diabetes.

Swiss company Roche has won approval for its Cobas Integra 800 Tina-quant HbA1cDx assay for marketing in the US. Behind the lengthy name is a piece of medical equipment to be used by health care professionals for diagnosing diabetes.

It is the first time the FDA has approved a so-called HbA1c-device – a measuring unit for long-term blood sugar – to diagnose diabetes. Until recently, equipment of this type had only been approved for monitoring blood sugar levels.

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