Medical device company Vasoptic Medical Inc reported on Tuesday the receipt of US Food & Drug Administration 510(k) clearance to market its XyCAM RI non-invasive retinal imager designed to capture and provide dynamic blood flow information for clinical use.
The company added that the XyCAM RI allows ophthalmologists and optometrists to use optical imaging technology for retinal examination and to monitor and manage age-related macular degeneration, diabetic retinopathy and retinal vein occlusions.
Through the 510(k) marketing clearance, the company said it can begin taking purchase orders for the XyCAM RI from hospitals, ophthalmology and optometry clinics and academic medical centres interested in integrating the retinal blood flow imager into daily practice.
In addition, the company plans to collaborate with academic research institutions to gather clinical evidence to support the expanded use of the XyCAM RI in specific disease conditions. The Abell Foundation has been its investor since the early stages of development.
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