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Zeiss receives FDA 510(k) approval for AngioPlex OCT Angiography technology

Zeiss Medical Technology has received 510(k) approval from the US Food and Drug Administration (FDA) for its AngioPlex optical coherence tomography (OCT) Angiography technology.

Zeiss

AngioPlex helps in providing high-resolution and depth-resolved visualization of the separate layers of the retinal and choroidal vasculature, without the use of an injected contrast dye, as it comes with fluorescein angiography (FA).

It clearly visualizes blood flow through detecting motion of scattering particles such as red blood cells within sequential OCT B-scans carried out repeatedly at the same location of the retina.

Zeiss Meditec president and CEO Dr Ludwin Monz said: "We are pleased to provide US doctors with a single OCT solution that allows them to make this revolutionary technology part of their daily clinical practice.

"As the first such system cleared in the US, AngioPlex OCT Angiography continues a long tradition of Zeiss delivering innovations that help improve clinical decision-making and, ultimately, outcomes for patients."

CIRRUS HD-OCT with AngioPlex will require a single additional OCT scan, compared to other OCT angiography systems that require multiple OCT scans to generate one single OCT angiography image.

Single OCT angiography image can be generated with the help of retinal tracking system FastTrac, which actively eliminates eye motion to provide motion-artifact-free images of the perfused retina. AngioPlex also uses Optical Micro Angiography (OMAG) Algorithms to offer ultra-clear vascular images.

AngioPlex OCT Angiography is available on the CIRRUS 5000 HD-OCT platform, according to the company.


Image: AngioPlex image of branch retinal vein occlusion. Photo: courtesy of Business Wire.