First AI medical diagnostic device approved by FDA

Signal of change / First AI medical diagnostic device approved by FDA

By Ella-Louise Micallef / 16 May 2018

The United States Food and Drug Administration has permitted the marketing of the first ever medical device that uses artificial intelligence to detect mild levels of diabetic retinopathy, an eye disease found in adults who suffer from diabetes. The device can be used by a primary care doctor, as opposed to an eye specialist, to determine whether the patient has “more than mild” or “negative for more than mild” diabetic retinopathy. If the device determines that they have more than mild symptoms, the patient is then recommended to a specialist for further evaluation and to begin treatment.

So what?

Diabetic retinopathy is the most common cause of vision loss amongst Americans living with diabetes. Many diabetic patients are not screened for it often enough, as only about half visit their eye doctor on a yearly basis. As this device can be used by a primary care doctor, without the need for a specialist to interpret the results, it could help prevent many more from going blind through early detection and treatment.

What impacts might AI diagnostics have on access to medical advice and treatment, across the world? What risks do you see, as well as benefits?

Sources

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357.htm

What might the implications of this be? What related signals of change have you seen?

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