T2 Biosystems (Nasdaq: TTOO), a company developing

T2 Biosystems (Nasdaq: TTOO), a company developing innovative diagnostic products to improve patient health, today announced that it has received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

This is from 6 months ago. There is an entity called the FDA which has to be reckoned with.