Zeiss Receives FDA Clearance for Clarus 700 Ultra-Widefield Imaging Device

Source: Zeiss

Zeiss announced that it has received FDA 510(K) clearance for the Clarus 700, high-definition, ultra-widefield imaging system. Clarus 700 is the first high-resolution ultra-widefield imaging with true color and a complete range of fundus imaging modalities, including fluorescein angiography, according to a company news release.

Ultra-widefield fluorescein angiography helps eye care specialists identify earlier more severe forms of diabetic retinopathy like neovascularization and retinal diseases such as uveitis, choroidal masses, retinal tears, detachments, and peripheral ischemia.

The high-resolution and high contrast images of the fluorescein angiography from the Clarus 700 allows clinicians to capture the smallest details from the macula in early phase to the periphery in late phase of fluorescein angiography. Powered by Zeiss’ “Broadline Fundus Imaging” the Zeiss Clarus 700 captures images that closely resemble the natural coloration of the fundus as it appears under direct clinical observation, according to Zeiss.

“I think the main goal of any fundus imaging system is to really get the pan-retinal view of the retina in true color. That’s where I think Clarus is going to make some major steps in that direction,” Jesse Jung, MD, from East Bay Retina Consultants, said in a company news release.

Using a simple and intuitive interface with time-saving data acquisition features, the Clarus 700 provides a comprehensive fundus exam that aids in diagnoses, treatment planning, and disease management. With its new features using deep learning algorithms, retina specialists can maximize the workflow efficiency in their practice and image all patient types including elderly and sick who may have trouble maintaining their fixation.

“Zeiss has been at the forefront of industry-defining advancements that have made Clarus the industry’s standard of care for identifying retinal and glaucoma disease,” Jim Mazzo, Global President of Ophthalmic Devices at Carl Zeiss Meditec, said in the news release. “From early detection to post-operative evaluation, we’re here to support our customers, every step of the way.”

With the Clarus 700, advanced care specialists can manage all needed capture modalities including: True color with RGB separation, autofluorescence-green, autofluorescence-blue, stereo image pairs, external eye and fluorescein angiography in one session from one device, all without having to reposition the patient, thus providing patients a comfortable exam experience.

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