XyCAM RI allows ophthalmologists and optometrists to rapidly evaluate vascular status of the retina for enhanced disease detection and treatment
US-based Vasoptic Medical has received the US Food & Drug Administration (FDA) 510(k) approval to market and sell its non-invasive retinal imaging device XyCAM Retinal Imager in the US.
The medical device company said that its XyCAM RI has been designed to capture and provide dynamic blood flow information for clinical use.
In addition, the device will enable ophthalmologists and optometrists to rapidly evaluate the vascular status of the retina for enhanced disease detection and treatment.
Vasoptic intends to start taking purchase orders for the XyCAM RI device
The regulatory approval enables Vasoptic to start taking purchase orders for the XyCAM RI from hospitals, ophthalmology and optometry clinics, and academic medical centres to integrate the retinal blood flow imager into daily practice.
In addition, the company intends to work together with academic research institutions to collect clinical evidence supporting the expanded use of the XyCAM RI in specific disease conditions.
Headquartered in Baltimore, Maryland, Vasoptic Medical is an early-stage, medical device company.
Since the early stages of Vasoptic’s development, the Abell Foundation has been a major supporter and investor in the company.
Vasoptic co-founder and general counsel M Jason Brooke said: “Our goal at Vasoptic is to develop and deploy innovative diagnostic tools to allow clinicians to better manage their patients’ disease.
“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.”