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Will FDA approve all AI-powered medical devices?


Will FDA approve all AI-powered medical devices?

The food and Drug Administration (FDA) is a federal agency which is responsible for safeguarding and promoting public health with the control on food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices and much more.

US Food and Drug Administration gave consent to IDx to market an AI-powered diagnostic device for ophthalmology. This software will help identify small amount of diabetic retinopathy which happens when blood sugar is high which leads to loss of vision.

An adult eye with the help of AI algorithm analyzes the eye with special retinal camera. Doctor will send images to the cloud server wherein the software shows the result. Recently, the FDA approved an AI-based software to identify stroke but this device does not require specialized doctor to interpret the image or result.

Scott Gottlieb, FDA commissioner said many such AI devices will get approval very soon. He said FDA is “taking steps to promote innovation and support the use of artificial intelligence-based medical devices.” AI devices will not be replacing doctors or any medical professionals this early.


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