But now that I think about it it's possible that proving it's efficacy and accuracy in identifying cancer cells might take more time than your average approval. It's not just a matter of proving that it's safe to use and the sheath performance is adequate, but the extra step is that it really can accurately distinguish cancer and non cancerous cells using the specified technique.
Should the Royal Melbourne Hospital buy 19 of Optiscan’s InVivage devices After TGA approval in the future?, page-10
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