A new device from Seeing Machines, an Aussie firm, has been given FDA approval to assess issues within the visual field of the eye.
Unlike traditional standard automated perimetry (SAP) devices, the TFA measures both eyes on currently [sic], and does the entire test of both eyes in approximately 5 minutes (including rest breaks within the test). The objectivity of the TFA test offers doctors the possibility of significant improvements over the test-retest variability issues that impact SAP. For patients it means an end to the button pressing associated with SAP – the only task required of the patient in the TFA test is simply to look at the display.
The clearance of the device by the FDA satisfies this regulatory hurdle and allows the TFA to be commercially introduced into the United States market – the largest healthcare market in the world. Receipt of this FDA clearance allows us to remain on track to meet our original objective of launching the TFA in late 2007, and as such the device will be exhibited at the upcoming Annual Meeting of the American Academy of Ophthalmology in New Orleans in November 2007.
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