My friends,
Another small step for Optiscan this week with TGA approval of the CONVIVO. A small step, but important step, and a necessary step. Yes, the CONVIVO has FDA and see CE Mark certification in America and Europe. Despite the FDA and CE validation, without TGA approval, and with the current health regulatory bureaucracy in Australia, introduction of the CONVIVO for neurosurgery would be difficult if not impossible. The TGA approval should now open doors to CONVIVO in Australia where, given its provenance, Australian neurosurgical centres should move to implement, perhaps even lead the way, in introducing confocal digital microscopy into brain tumour surgery. God knows, it’s not before time. This would certainly be an Important milestone and Tiresias would expect significant media and public interest in Australia, and hopefully around the world. After so many decades of no improvement in survival of patients with malignant brain tumour, a good news story in this field will resonate. TGA approval is also an important confirmation that the technology meets the most rigorous requirements in the most difficult surgical field, brain surgery. Approval of in Optiscan’s vivo microscopy for all other applications is a foregone conclusion. There are of course usual usual bureaucratic processes, which are always too slow for all of us, but their successful negotiation is now inevitable.
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