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PLEX Elite 9000 from Zeiss receives FDA clearance
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The FDA has cleared the PLEX Elite 9000 for advanced retina research, Carl Zeiss Meditec announced in a press release.
This is the FDA’s first clearance for swept-source OCT imaging technology for posterior ocular structures, the release said.
The platform, which consists of swept-source OCT as well as OCT angiography, provides wide-field high-resolution imaging of the microstructures and microvasculature of the posterior segment.
U.S. members of the Advanced Retina Imaging (ARI) Network, a global consortium of clinicians and scientists who work in retinal disease research, may be able to enroll patients more easily and facilitate faster Institutional Review Board reviews for research approval because of the FDA clearance, according to the release.
“This instrument opens up a new world of structural and microvascular clarity. By imaging deeper and in greater detail than ever before, we will further our understanding of the retina and choroid, and greatly facilitate clinical trial investigations into different diseases,” Philip J. Rosenfeld, MD, PhD, chairman of ARI Network, said in the release.
There is a limited release of the PLEX Elite 9000 platform for retina research.