Eyenuk gets FDA okay:

Eyenuk, Inc, a global artificial intelligence (AI) medical technology and services company and the leader in real-world applications for AI Eye Screening, has announced that it has received 510(k) clearance (K200667) by the US Food & Drug Administration (FDA) to market its EyeArt® autonomous AI System for diabetic retinopathy, a leading cause of blindness among American adults.

EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy. EyeArt is the first FDA cleared autonomous AI technology that can detect both mtmDR and vtDR in one test, in primary care and eye care settings. In addition, EyeArt is also the first FDA cleared autonomous AI technology that has diagnostic outputs for each eye of a patient.

Diabetic retinopathy (DR) is a common complication of diabetes. It is characterized by progressive damage to the blood vessels of the retina, the light-sensitive tissue at the back of the eye that is necessary for good vision. According to CDC, an estimated 4.1 million and 899,000 Americans are affected by retinopathy and vision-threatening retinopathy, respectively. It is estimated that number of vision-threatening diabetic retinopathy patients around the world will reach 56.3 million by 2030.

While DR screening is recommended for all diabetic patients, less than half get screened annually, even in the developed world. (AP)