Eyenuk recently received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system, which automatically detects diabetic retinopathy. The company said this FDA clearance makes its system the only AI system that is FDA-cleared for use with multiple retinal cameras produced by different manufacturers.
Eyenuk, a company that makes technology for eye screenings, raised $26 million in a Series A funding round, bringing its total funding to more than $43 million. Research shows that the company's AI system is more accurate in detecting diabetic retinopathy than a clinical examination from a general ophthalmologist or a retina specialist.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The agency set a national payment amount for AI-based screenings for diabetic retinopathy in its 2022 Medicare Physician Fee Schedule final rule. It would also allow the screenings to count toward quality measures.
AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, coming months after it committed $90 million to preclinical-stage Capsida Biotherapeutics.
The Centers for Disease Control and Prevention found that diabetes-related blindness costs can total more than $500 million per year, but eye care screenings are one of the easiest and most cost-effective ways to detect diabetes early and get patients the treatment they need.
The organizations have announced that the first real-world clinical use of the algorithm is happening at the Aravind Eye Hospital in Madurai, India.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The company's technology for screening diabetic retinopathy was granted "Breakthrough Device" designation and is able to provide a clinical decision, instead of simply a recommendation to the physician.
The marketing clearance follows the FDA's decision to approve a "breakthrough device" designation for IDx-DR, accelerating the review process for the product based on its ability to address an unmet medical need.
The system has an artificial intelligence algorithm that evaluates the images coming from the camera and determines whether or not there's diabetic retinopathy in them,” explained IDx Founder and President Michael Abràmoff. “So it makes a clinical decision, without someone like me being involved — it's fully autonomous.”