Get caught up on the approvals and hear directly from Kaushal Solanki, PhD, Founder and CEO of Eyenuk.
Eyenuk has received U.S. Food and Drug Administration (FDA) clearance for the use of the Topcon NW400 retinal camera in association with the company’s EyeArt AI system for the automatic detection of diabetic retinopathy. This joins the Canon CR-2 AF and Canon CR-2 Plus AF cameras, which have already been approved for use with the company’s Ai system. This makes the EyeArt v2.2.0 system the first AI system to be FDA-cleared for use with multiple cameras by different manufacturers.1
This clearance comes after a multi-center clinical trial (NCT04984200) showed 94.4% sensitivity and 91.1% specificity for more-than-mild DR detection, and 96.8% sensitivity and 91.6% specificity for vision-threatening DR detection.
The FDA’s decision also includes Real-Time Image Quality Feedback and an upgraded image quality assessment module, achieving best-in-class gradability (conclusive reports) without eye dilation.
The system has also been approved by the European Union under the MDR class IIb to perform a single test that can detect DR, age-related macular degeneration (AMD), and glaucomatous optic nerve damage.
To further discuss this clearance for the EyeArt system, the Ophthalmology Times team say down with Kaushal Solanki, PhD, Founder and CEO of Eyenuk.
Editor's note - This transcript has been edited for clarity.
David Hutton: I'm David Hutton of Ophthalmology times. This week, Eyenuk received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy. Joining us to discuss this clearance is Dr. Kaushal Solanki, founder and CEO of Eyenuk. Thank you so much for joining us today. Tell us what this means for ophthalmologists and the patients they treat.
Kaushal Solanki, PhD: Thank you, David for having me. So with this expansion of EyeArt, our flagship AI product for autonomous detection of diabetic retinopathy, which was formally cleared for use with Canon cameras, we now have clearance with Topcon camera as well. Making it the first and only system that is cleared by the FDA for use with multiple camera systems or multiple camera models from different manufacturers. What it means for the community is that now they have choices. Now, they can use the fully automated Topcon camera, or they can use the Canon camera with excellent imaging and resolution. So this also means that we have the community, the clinicians have additional choices, they may have these cameras already installed, and they can just get just a software upgrade with EyeArt and start using AI in the practice. So it means greater access to patients. That is one of the primary thing we are achieving through this clearance.
David Hutton: Tell us a little bit about the technology that's received the clearance.
Kaushal Solanki, PhD: So the technology is, it's a series of artificial intelligence algorithms that detect lesions related to diabetic retinopathy to provide output that is either more than mild diabetic retinopathy or vision threatening diabetic retinopathy. We are the only FDA cleared system that is approved for detecting vision threatening disease. Which has been true since our first initial clearance in 2020. What we also bring to market through this clearance is an upgrade to the image quality assessment module. And we are also providing to our customers a real time image quality feedback. Youu know, this does get a bit technical. But what it does for our customers is that it brings patient and clinic friendly features to the market.Achieving the best in class gradeability without dilation. So in a clinical trial that was used to support this clearance, we achieved over 90% gradeability without dilation, which is a significant upgrade or, you know, some competition where you know, they needed like a quarter of patients needing dilation. So this is also a significant upgrade that we are bringing to the market today.
David Hutton: One of the things that I've heard from a few people I've talked to is the cost in reimbursements. Could this pose a hurdle? Or how is this a challenge that you could overcome?
Kaushal Solanki, PhD: This technology is reimbursed by Medicare through a new Category 1, CPT code called 92229. That doesn't change. Meaning to say this reimbursement has been, a national reimbursement has been in place since 2022. And now, what what this upgrade brings is that those customers with different camera models are now compatible, and they can start using AI for instant reads, and they can also be reimbursed by Medicare and commercial payers.
With this clearance. Does this mean that the new option is available now? Or if not, when will it be available to ophthalmologists?
It's available now.
David Hutton: And what impact can this have on say the workflow of a practice? How can it make an ophthalmologist more efficient?
Kaushal Solanki, PhD: This will make the clinicians more efficient, for one, by all the usability features that I just talked about. The real time quality feedback, so when the patient is there, they get feedback on image quality through use of artificial intelligence, and the new image can be taken right away if the [original image] is no good. And so that significantly improves the patient workflow. For vast majority of patients over 90%. They get an actionable conclusive EyeArt report without needing dilation, but if dilation is to be recommended for the other, you know, less than 10% the software itself makes that recommendation. It really makes the workflow very seamless.
David Hutton: Lastly, is there anything that maybe I haven't asked you today?
Kaushal Solanki, PhD: So this upgrade goes to our existing customers, you know, with the likes of, you know, Temple University and several others. It also allows those with the Topcon camera to just upgrade and start using AI. We are also the first and only system that is cleared by EU under a Class IIb MDR, for detection of multiple diseases; diabetic retinopathy, AMD and glaucoma. So, and that all goes towards our mission to screen every eye in the world to ensure timely diagnosis of vision threatening conditions.