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Carl Zeiss Meditec software application receives clearance for use with automated perimeter
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DUBLIN, Calif. — The U.S. Food and Drug Administration has granted Carl Zeiss Meditec's Guided Progression Analysis software 510(k) class II clearance for use with its Humphrey Field Analyzer II-i, the company announced in a press release.
The Humphrey Field Analyzer II-i is the first automated perimeter equipped with Guided Progression Analysis software that has received clearance from the FDA for assessing visual field loss over time, the release said.
Indicated for detecting visual field loss associated with glaucoma and other ocular disease, the software is capable of evaluating changes in visual field loss, including changes from baseline and rates of change. The module can then assemble visual field test results on a single page and calculate a patient's rate of visual field deterioration.
"The Humphrey Field Analyzer has been the leading perimeter in the eye care industry for more than 25 years, and we are excited to have achieved another important milestone with the FDA's clearance of [Guided Progression Analysis] software," Ludwin Monz, CEO of Carl Zeiss Meditec, said in the release. "Our commitment to leadership in glaucoma continues as we seek to deliver technological enhancements that will allow practitioners to better detect and treat glaucoma, one of the leading causes of vision loss in the world today."
Guided Progression Analysis software also is available for Carl Zeiss Meditec's Cirrus HD-OCT platform.
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