FDA approves first AI-powered diagnostic that doesn’t need a doctor’s help
On Wednesday the US Food and Drug Administration gave permission to a company called IDx to market the first diagnostic device that uses artificial intelligence. The approval marks medicine’s entrance into an era of “diagnosis by software.”
What it does: The software program is designed to detect greater than a mild level of diabetic retinopathy in adults, which causes vision loss and affects 30 million people in the US with diabetes. It occurs when high blood sugar damages blood vessels in the retina.
How it works: The software uses an AI algorithm to analyze images of the eye taken with a special retinal camera. A doctor uploads the images to a cloud server, and the software then delivers a positive or negative result.
A regulatory milestone: The FDA has recently cleared a few other products that use AI. But this is the first device authorized by the agency to provide a screening decision without the need for a doctor to also interpret the image or results.
A look ahead: In a series of tweets by FDA commissioner Scott Gottlieb today, he hinted that more AI devices could get the agency’s seal of approval soon. Gottlieb said the FDA is “taking steps to promote innovation and support the use of artificial intelligence-based medical devices.” Not to worry, though: such AI diagnostics probably won’t be replacing doctors or other medical professionals anytime soon.
via MIT Technology Review http://bit.ly/2lPKd7t
April 11, 2018 at 01:06PM