Vasoptic Medical Receives FDA 510(k) Clearance for Retinal Imaging Device
Vasoptic Medical has received 510(k) clearance from the FDA for its XyCAM RI noninvasive retinal imager.
The XyCAM RI provides dynamic and quantifiable blood flow measurement synchronized with finger pulse oximeter data. The device images retinal vessels and blood flow with high spatio-temporal resolution, high reproducibility of measurements, and dynamic flow-sensitivity over a wide range, according to Vasoptic. The device provides multiple display modes for different applications, including reconstructed fundus image mode, dye-free angiogram mode, and colored flow visualization mode.
“Today’s announcement represents an important milestone. 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,” Abhishek Rege, President and Founder of Vasoptic, said in a company news release. “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.”
“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,” M. Jason Brooke, Co-Founder and General Counsel at Vasoptic, said in the news release. “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.”
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.