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FDA Approves Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

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The FDA has permitted marketing of IDx-DR (IDx LLC)--the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults. "Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% of them do not see their eye doctor on a yearly basis," said Malvina Eydelman, MD, Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA's Center for Devices and Radiological Health. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office.


AI is being used to spot the signs of a diabetes-induced eye disease

Daily Mail - Science & tech

One hospital is now allowing artificial intelligence to take the reigns and diagnose its patients. The UI Health Care-Iowa River Landing in Coralville, Iowa has become the first hospital to adopt a new AI-powered machine to spot the early warning signs of diabetic retinopathy. If left undiagnosed, the condition, which arises as a complication for patients who suffer with either type one or type two diabetes, can cause blindness. The machine is capable of scanning and analysing the retinas of at-risk patients and will provide its own diagnosis without any human assistance. Dubbed IDx-DR, the technology has an 87 per cent sensitivity for the disease.


AI Tool Detects Diabetes-Related Eye Condition Without Human Interpretation - AI Trends

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Last year, IDx-DR became the first-ever so-called "autonomous AI" system cleared by the FDA to provide a screening decision without the oversight of a doctor. Since then, IDx Technologies, the company behind the product, has begun to roll out this tool designed to detect diabetic retinopathy. Over 30 million people are living with diabetes in the US alone. "The disease itself is bad," said Michael Abramoff, a University of Iowa ophthalmologist and computer scientist, "but the complications make it even worse." One of those complications is diabetic retinopathy, the leading cause of blindness in American adults.



8 AI Diagnostics and Imaging Startups for Digital Health

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Investing in emerging technologies can be extremely risky. It can also be extremely rewarding – and not just for your bank account. Technologies like artificial intelligence have the potential to change the world in many different ways. One of the industries where AI is already making real advances is healthcare, such as the ability to design and validate drug candidates to treat disease in less than two months. That has attracted the attention of plenty of deep-pocketed investors into AI healthcare startups, which have made more deals than any other AI industry since 2014, according to research firm CB Insights, with more than 80 AI diagnostics and medical imaging companies leading the way across 150 deals and counting.