ZEISS Sets the Pace in OCT Innovation with First FDA 510(k) Clearance of OCT Angiography Technology

AngioPlex OCT Angiography from ZEISS is the next generation of vascular imaging, providing non-invasive 3D images of blood flow in the eye to help eye care professionals detect retinal diseases earlier and improve treatment and management of these diseases
DUBLIN, Calif.–(BUSINESS WIRE)–ZEISS Medical Technology announces that its AngioPlex OCT Angiography is the first such technology to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA).

“As the first such system cleared in the U.S., AngioPlex OCT Angiography continues a long tradition of ZEISS delivering innovations that help improve clinical decision-making and, ultimately, outcomes for patients.”

With a single additional OCT scan that takes just seconds on the CIRRUS HD-OCT system from ZEISS, ophthalmologists can now utilize optical coherence tomography (OCT) images to assess the blood vessels (vasculature) of the retina at a depth and clarity never available before. AngioPlex OCT Angiography delivers high-resolution, depth-resolved visualization of the separate layers of the retinal and choroidal vasculature — without the need for an injected contrast dye, as is standard with fluorescein angiography (FA).
The information provided by these images is clinically impactful, because progression of retinal diseases is often accompanied by changes in the vasculature of the eye. In age-related macular degeneration (AMD), diabetic retinopathy, central retinal vein occlusion and other vascular conditions, AngioPlex OCT Angiography can complement traditional FA and become a safe and efficient part of routine eye care, potentially enabling earlier detection and management of micro-progressions.
“OCT angiography ushers in a new era in the evaluation of the retina in diabetic retinopathy and macular degeneration,” said Carmen Puliafito, MD, dean of the Keck School of Medicine of the University of Southern California and one of the co-inventors of OCT. “Retinal specialists will now be able to obtain high-resolution cross-sectional images of the macula coupled to the most detailed visualization of the retinal vasculature ever achieved. This unique capability promises to revolutionize clinical decision making in retinal pharmacotherapy.”……
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Source: Business Wire