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The device recently received 510(k) clearance from the US Food and Drug Administration.
AI Optics, an AI-focused medical device company, recently received FDA 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system.
Sheryl Stevenson, Executive Editor at Ophthalmology Times, sat down to talk with Kathryn A. Colby, MD, PhD, Chair, NYU Langone Department of Ophthalmology to discuss this clearance and benefits of the device. AI Optics is collaborating with NYU Langone Health with the goal of advancing the accessibility and implementation of retinal screening technology.
“I’ve actually played with their version 2.0 of their device, but it’s a handheld device that is so simple that even a chairman could take a picture of a retina with it,” said Colby. “It’s a handheld device almost like a small hair dryer, it fits over the eye and it’s not invasive. Once the image is received, the AI in the device […] reads the photograph and can tell–needs further evaluation or [it] looks good.”
Colby discussed the impact the Sentinel Camera could have on screening patients, most importantly diabetic patients as well.
“It’s not really so much a help for retina specialists, or ophthalmologists, or even optometrists because we are all pretty good at looking at the retina, but what we as a country do fairly poorly on is screening our diabetics for diabetic retinopathy. I think the number I have heard is maybe about 30% of diabetics actually get yearly eye exams. So it is really for that space, the primary care doctor, the endocrinologist, to be able to have something that gives you some impression of what is going on in the retina.”
Colby also commented that the mobility of the camera could help in communities where access to care may be limited.
“We have room for improvement for how we are screening our diabetics. So, this will really help with that. You can imagine it being used in communities where people don’t have reliable access to ophthalmologists or optometrists and really do a better job of preventable–diabetic retinopathy is a form of preventable blindness in working age adults so it is a significant health problem.”
As previously reported, in addition to the clearance, AI Optics is developing AI-based retinal screening software for future integration. The company aims to provide a comprehensive end-to-end solution for detecting retinal diseases such as diabetic retinopathy, glaucoma, and macular degeneration.