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FDA okays AI-driven device to identify diabetic retinopathy

by Thomas Dworetzky , Contributing Reporter
AI may soon be able to spot the most common cause of vision loss linked to diabetes.

The FDA has OK'd the marketing of the IDx-DR, the first autonomous, AI-based system to diagnose diabetic retinopathy, a leading cause of blindness.

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Calling the decision "a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered," Dr. Michael Abràmoff, founder and president of Idx noted in a company statement that, "autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality.”

The development of the system, he added, “provides a roadmap for the safe and responsible use of AI in medicine."

More than 30 million Americans have diabetes, of which nearly 24,000 lose vision each year from diabetic retinopathy. If detected early, the condition is almost entirely preventable, according to the company.

The device can be used in a primary care setting, can test for the condition in minutes, and its report comes with care instructions OK'd by the American Academy of Ophthalmology. It lets a primary care doctor advise a patient without the need for the additional time and expense of a specialist visit.

"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 percent of them do not see their eye doctor on a yearly basis," said the FDA's Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health.

The device, from the Iowa-based company, was reviewed using new FDA regulations designed to ease the approval of a low- or moderate-risk medical product when there is nothing else like it on the market.

“The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care,” said Eydelman, according to Reuters.

AI for healthcare was also in the news in February, when the FDA cleared the Arterys Oncology AI suite, a web-based system allowing clinicians to measure and track tumors or potential cancers and apply radiological standards – specifically useful for liver MR and CT scans, and lung CT scans.

And in ongoing IBM Watson Health news, Elekta announced in January that it would join with the legendary computer software giant to develop an interface able to bring together the capabilities of Elekta’s MOSAIQ Oncology Information System and IBM’s Watson for Oncology platform.

“This interface will be able to upload patient data, including the lab reports, the documents and diagnoses, and patient information, directly from MOSAIQ into the Watson products,” Andrew Wilson, vice president of global marketing, software, at Elekta, told HCB News. “From a physician’s perspective, it will become a relatively seamless operation. The data will be uploaded with a click, and information will be ready in Watson for it to build analysis. It will mean that when sites are configured with MOSAIQ and Watson, they’ll have this functionality."

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