Baltimore-based medical device company Vasoptic Medical Inc. received 510(k) clearance from the U.S. Food & Drug Administration to market its XyCAM RI, a non-invasive retinal imager designed to capture and provide dynamic blood flow information for clinical use.
The XyCAM RI can allow ophthalmologists and optometrists to rapidly and affordably assess the vascular status of the retina, which can improve disease detection and treatment.
The issuance of the 510(k) clearance authorizes Vasoptic to market and sell the XyCAM RI in the United States.
Ophthalmologists and optometrists predominantly use optical imaging technology for retinal examination and to monitor and manage a variety of conditions, including age-related macular degeneration, diabetic retinopathy, and retinal vein occlusions. These diseases affect the daily lives of millions of people and may be indicative of more systemic medical conditions.
As an example, diabetic retinopathy is a condition that affects nearly 1 in 3 diabetic patients and, if unmanaged, leads to severe vision impairment and blindness. According to the International Diabetes Federation, more than 31 million individuals in the US suffer from diabetes and globally the population of diabetics is nearly half a billion.
With the grant of the 510(k) clearance, Vasoptic can begin taking purchase orders for the XyCAM RI from hospitals, ophthalmology and optometry clinics, and academic medical centers interested in integrating the retinal blood flow imager into daily practice. In addition, Vasoptic intends to continue to collaborate with academic research institutions to gather clinical evidence to support the expanded use of the XyCAM RI in specific disease conditions.