Carl Zeiss Meditec receives FDA clearance for OCT posterior ocular imaging system

The FDA has approved a swept-source optical coherence tomography (OCT) posterior ocular imaging system.

Carl Zeiss Meditec (Dublin, CA) has received FDA approval for the ZEISS PLEX Elite 9000 swept-source optical coherence tomography (OCT) posterior ocular imaging system, which allows the potential to see deeper, wider, and in more detail from vitreous to sclera. The system expands the potential for clinical researchers to open new frontiers of discovery in diseases affecting the retina.

Related: Zeiss receives FDA approval for OCT angiography technology

The ZEISS PLEX Elite 9000 system, which pairs swept-source OCT and OCT angiography, was designed for advanced retina research and is at the core of the Advanced Retina Imaging Network.

The network, led by Philip J. Rosenfeld, MD, Ph.D., is a unique global consortium of clinicians and scientists from around the world working at the forefront of retinal disease research. It focuses on exploring new clinical applications for the diagnosis and treatment of eye disease, and advancing OCT innovation to benefit patients today and in the future. The FDA clearance will help U.S. members of the network to more easily enroll patients, and may facilitate faster Institutional Review Board (IRB) review for protocol approval of research.

ZEISS PLEX Elite 9000 offers researchers the potential to assess early mechanisms for micro- and neovascularization, to explore the progression of retinal and choroidal pathology, to deepen the understanding of choroid physiopathology, and to evaluate mechanisms of retina and choroid response to therapy.

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