Medical device company Vasoptic gains FDA clearance for new retinal imaging technology
Vasoptic Medical, an early-stage medical device company, has gained U.S. Food and Drug Administration clearance for its optical imaging technology that measures dynamic blood flow in the retina.
The 510(k) designation allows the Baltimore firm to market and sell its XyCAM RI system in the United States, according to the June 9 announcement.
Ophthalmologists and optometrists can use the device to image blood flow dynamics during retinal exams, helping them spot age-related macular degeneration, diabetic retinopathy, and retinal vein occlusions. Millions are affected by these diseases, the company noted, and some are indicative of more serious medical problems.
President and Co-founder of Vasoptic, Abhishek Rege, says such findings can “dramatically impact the vision and quality of life for millions of Americans."
The Abell Foundation—dedicated to improving the quality of life in Maryland, with an emphasis on Baltimore—was an early investor in Vasoptic, and says the new tool can improve detection in its community, which has been disproportionately affected by retinal diseases.
Vasoptic also plans to collaborate with academic research institutions to combat these eye conditions.
“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,” said M. Jason Brooke, co-Founder and general counsel at Vasoptic.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.