ZEISS's Medical Technology Segment announced that it has received 510(K) clearance from the FDA for the CLARUS® 700, High-Definition, Ultra-Widefield Imaging system for advanced care specialists. CLARUS 700 is the first high-resolution ultra-widefield imaging with true colour and a complete range of fundus imaging modalities, including fluorescein angiography (FA).
Ultra-widefield fluorescein angiography helps eye care specialists identify more severe forms of diabetic retinopathy earlier, like neovascularisation and retinal diseases such as uveitis, choroidal masses, retinal tears, detachments and peripheral ischaemia.
The high-resolution and high contrast images of the FA from the CLARUS 700 allow clinicians to capture the smallest details from the macula in early phase, to the periphery in late phase of FA.
Powered by Broadline Fundus Imaging, the ZEISS CLARUS 700 captures images that closely resemble the natural colouration of the fundus as it appears under direct clinical observation.
“I think the main goal of any fundus imaging system is to really get the pan-retinal view of the retina in true colour. That’s where I think CLARUS is going to make some major steps in that direction,” stated Jesse Jung, MD from East Bay Retina Consultants.
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 advanced new features using deep learning algorithms, retina specialists can maximise the workflow efficiency in their practice and image all patient types, including the 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,” said Jim Mazzo Global President of Ophthalmic Devices at Carl Zeiss Meditec. “From early detection to postoperative evaluation, we’re here to support our customers, every step of the way,” he added.
With the CLARUS 700, advanced care specialists can manage all necessary capture modalities including true colour with RGB (red, green, blue) 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.