Artificial intelligence medical equipment approved for listing in the United States
According to news from the US Food and Drug Administration's official website on the 11th, the agency approved for the first time the sale of medical equipment using artificial intelligence (AI) technology. The software program is named 'IDx-DR' and will Used to screen diabetic retinopathy, which does not require analysis by a human clinician to generate a diagnosis.
Abnormal insulin metabolism in diabetic patients can cause changes in the microcirculation of the eye tissues, nerves, and blood vessels, causing eye damage. Diabetic retinopathy is one of the serious complications of diabetes and one of the major blinding eye diseases.
According to an FDA announcement, 'IDx-DR' is the first medical device approved in the United States that can give results without the need of clinician analysis. The software uses an artificial intelligence algorithm to perform retinal images captured by Topcon NW400 cameras. analysis.
The doctor takes pictures of the subject's retina and uploads the image to a cloud server with the software. If the image quality reaches standard The software will automatically generate the results after analysis. The software can provide one of the following two results to the doctor: 'Detection of mild diabetic retinopathy above, consult ophthalmologist', or 'Not detect mild above diabetic retina Lesions, please retest in the next 12 months'.
According to the clinical test of 900 patients with diabetes, the accuracy of the artificial intelligence software was 87.4% for patients with mild or more diabetic retinopathy, and 89.5 for those without mild diabetic retinopathy. %.
According to Marvina Edelman, director of ENT at the FDA's Medical Equipment and Radiological Center, the number of people with diabetes is currently quite large. Early diagnosis of diabetic retinopathy is very important for them. About 50% of patients do not See an ophthalmologist every year, and this artificial intelligence software allows patients to be effectively screened at the primary community clinic.
The FDA said that in the future, they will continue to promote safe and effective digital medical devices onto the road to practical application.
