Vasoptic Medical’s Retinal Imaging Device Receives FDA 510(k) Clearance

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Vasoptic Medical Inc. announced today that the company 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. “Today’s announcement represents an important milestone,” said Abhishek Rege, President, and Founder of Vasoptic. “After tremendous effort from a tremendous team of engineers, scientists, and clinicians, the FDA authorization will enable physicians to better understand the physiological status of their patient’s retina. Specifically, the XyCAM RI provides imaging of blood flow dynamics in the retina, the next frontier for ophthalmic imaging, and will allow physicians to make decisions about care that could dramatically impact the vision and quality of life for millions of Americans.”

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 maybe 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.

“Our goal at Vasoptic is to develop and deploy innovative diagnostic tools to allow clinicians to better manage their patients’ disease,” said M. Jason Brooke, Co-Founder and General Counsel at Vasoptic. “The XyCAM RI adds to the clinician’s toolbox an ability to capture dynamic physiological information that can meaningfully improve their understanding of the condition and disease progression. It is our hope that clinicians in the future will leverage the blood flow information from the small vessels of the retina to generate new ways to manage and treat ophthalmic diseases like glaucoma or diabetic retinopathy but also systemic diseases like diabetes, hypertension, or sleep apnea.”

The Abell Foundation has been a major supporter and investor in Vasoptic since the early stages of the company’s development. Robert C. Embry, Jr., President of the Abell Foundation, commended the company on reaching this important milestone. “As an organization working to enhance the quality of life in Baltimore and Maryland, the Abell Foundation recognizes the disproportionate impact retinal diseases have in our community that too often go undetected. Vasoptic Medical’s XyCAM RI has the potential to change the lives of those we seek to serve,” Embry said. “We look forward to continuing to support the Vasoptic team as the product is deployed in clinics around Baltimore, Maryland, and the rest of the country.”

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.



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