Don't think they have yet, they'd need to get the data peer reviewed first before they begin going through the FDA approval process for closed angle glaucoma. However the preliminary data they've presented at conferences looks very impressive, and is probably why it has become quite core topic at recent conferences for Nova Eye Medical. They'd probably take the 510(K) route which will mean it should be quickly approved when the data is ready.
This is an announcement from late last year, if they can get it approved quick that's an extra 30 million patients who currently have very limited treatment options (zero MIGS options), and are at a much higher risk of blindness than open angle glaucoma patients.![]()
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Don't think they have yet, they'd need to get the data...
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