AI caring for patients

The U.S. Food and Drug Administration approves the first medical devices with autonomous artificial intelligence

Written Tuesday, by Emanuele Mortarotti

Welcome back to our weekly appointment with curiosities and news selected for you by the Dispotech team!


For the first time the FDA (Food and Drug Administration - a US government agency that regulates food and pharmaceutical products) has approved the introduction on the market of a medical device that uses AI and does not require a physician to interpret its inputs. Let’s see what is this all about thanks to a piece published on


Only a few months ago IDx an Iowa-based company, received approval to market its retinopathy-detecting software, IDx-DR. This is the first screening device FDA has ever authorized for sale that does not require an interpretation by a physician.

The device’s software uses artificial intelligence to analyse images of the eye, judging whether or not they show signs of diabetic retinopathy.

During a clinical trial, the software correctly detected the condition 87% of the time, and 90% of the time, in perfectly healthy people, ruled out the existence of the condition. Because the algorithm works on its own, providers of the medical sector who aren’t eye specialists, can use this medical device to screen for diabetic retinopathy.

“Autonomous AI systems have enormous potential for growth and a huge potential for improvement in health care productivity, lower prices, accessibility and quality,” says Dr Michael Abramoff, founder and president of IDx in a note released by the scientific press.

The healthcare industry has been trying for years to install Artificial Intelligence in its equipment. “The combination of healthcare and technology is at a delicate and crucial moment," says Chris Mansi, CEO of, a software and AI company. “Artificial intelligence is a tool that broadens the access to excellent healthcare resources, so that patients around the world will benefit equally from advances in scientific research.

In order for this to happen, however, health care organisations will be in a limbo and will invest in relatively young technologies, which still have to show a tangible economic return on the investments made. They should also encourage healthcare professionals to “do more than just confirming the diagnosis after the work done by AI-equipped equipment," says Kimber Lockhart, chief technology officer at One Medical, one of the best primary care companies in the US. “We would like for doctors to focus on understanding all the needed variables when it comes to the health of each individual.  And this is where you  can really see the value and the opportunity that these medical devices can give to society”.

FDA rated the above medical device as "sensational," which allowed the equipment to be approved so quickly. This approach is part of an FDA strategy to become faster at validating effective devices, making it possible to market them in a timely manner.


What do you think of this medical device? Do you believe that artificial intelligence will be the future of healthcare? Have your say by contacting Dispotech, your disposable excellence.

Emanuele Mortarotti
Author Emanuele Mortarotti


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