Software That Uses Artificial Intelligence To Screen Eyes For Diabetes Damage Approved By FDA
It's the first screening device the FDA has authorized that doesn't need a clinician's interpretation to look for a particular condition. In other news, the agency also is going to relax its review of next-generation sequencing tests.
FDA Grants First Approval To Autonomous AI-Powered Medical Device
For the first time, the Food and Drug Administration has approved marketing a medical device that uses artificial intelligence that doesn't require a clinician to interpret the input. On Wednesday, IDx, an Iowa-based company, received approval to market its retinopathy-detecting software, IDx-DR. This is the first screening device the FDA has authorized that doesn't need a clinician's interpretation to look for a particular condition. The device's software uses artificial intelligence to analyze images of the eye, judging whether or not they show signs of diabetic retinopathy. (Arndt, 4/12)
FDA To Relax Its Review Of Some Next-Generation Genetic Tests
The Food and Drug Administration will relax its review of some genetic tests that examine millions of different variants at the same time, the agency announced Thursday. So far, the FDA has not approved any of these broad “next-generation sequencing” tests, but as their cost drops, the agency believes they have more potential to help patients. (Swetlitz, 4/12)