The AI Doctor Will See You Now


Machine-learning algorithms accomplish tasks by training on a set of data, rather than being programmed by humans. Armed with the knowledge of what worked before, the system instructs the implant to stimulate users' brains to interrupt a seizure at its onset. The innovation is part of a larger phenomenon that has big implications for how we identify and treat disease: the introduction of artificial intelligence to consumer and clinical electronics. As machines learn from at times millions of humans, doctors are gaining the ability to better identify disease and even predict it before it becomes catastrophic. As in every other area of human endeavor, the introduction of AI to medicine comes with challenges.

FDA Approved IDx-DR AI That Helps Doctors Diagnose Eye Disease


US Food and Drug Administration (FDA) has approved IDx-DR AI; an artificial intelligence diagnostic device that doesn't need a specialized doctor to interpret the results and can detect a form of eye disease by looking at photos of the retina. IDx-DR is part of a growing trend of algorithms learning how to spot and diagnose disease. The best or say the unique part of this AI is, it is autonomous i.e there is no specialist looking over the system, which means it makes the clinical decision on its own, which again means that this technology can be used by a nurse or doctor who's not an eye specialist. In one clinical trial, this IDx-DR AI system was given more than 900 images and this system has correctly detected retinopathy about 87 percent of the time, moreover, it could correctly identify those who didn't have the disease about 90 percent of the time, which is appreciative in the field of artificial intelligence. For your info; Diabetic retinopathy is the most common vision complication people with diabetes, but is still fairly rare -- there are about 200,00 cases per year.

FDA chief moves to promote artificial intelligence in health care


The Food and Drug Administration (FDA) is moving to encourage the use of artificial intelligence (AI) in health care, the agency's chief said Thursday. "AI holds enormous promise for the future of medicine," FDA Commissioner Scott Gottlieb said in prepared remarks to the Health Datapalooza conference in Washington, D.C. He said the FDA is working on an updated "new regulatory framework" that will allow regulators to keep up with new technology and "promote innovation in this space." "We expect to see an increasing number of AI-based submissions in the coming years, starting with medical imaging devices, and we're working with experts in the field," he said. As an example of the new health technology he is seeking to promote, Gottlieb pointed to a new medical device approved by the FDA earlier this month that uses artificial intelligence and a special camera to help diagnose a condition in people with diabetes known as retinopathy that can lead to vision loss.

FDA Approves AI That Can Analyze Your Eyes


IDx-DR is a software program that can detect a certain type of eye disease from photos of a human retina, and it was just approved by the US Food and Drug Administration (FDA). This is a huge win for artificial intelligence (AI) and MedTech development: this is the first time the FDA has approved an AI-powered diagnostic device that doesn't require a doctor to interpret the results. Diabetic retinopathy is an eye disease in which an excess of blood sugar damages blood vessels located in the back of the eye. It's the most common vision malady for people afflicted with diabetes, with about 200,000 new cases occurring per year. After photos of a patient's retina are taken with a special retinal camera, IDx-DR's algorithm verifies that the picture quality is good enough to use for analysis.

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


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.

The FDA just opened the door to let AI make medical decisions on its own – Quartz


The US Food and Drug Administration approved this week the first software powered by artificial intelligence that replaces the need for a specialized doctor to interpret medical imagery. The software is called IDx-DR, made by diagnostic AI startup IDx, and specifically analyzes images of the retina to detect whether a person with diabetes has a complication from the disease called diabetic retinopathy. "IDx-DR is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care," the FDA wrote in a press release. Diabetic retinopathy is a complication of diabetes where blood sugar damages the back of the eye, according to the FDA, and is the main cause of the loss of vision for those with diabetes. To use the software, a doctor takes a retinal image with a specific model of camera and uploads it to IDx-DR's cloud service.

FDA approves first software that can interpret images without doctor's help


The Food and Drug Administration has approved the first artificial intelligence software that can decide, without a clinician's involvement, whether a patient might have a certain disease, the agency announced Wednesday. The software, called IDx-DR, looks for diabetic retinopathy, an eye disease that afflicts individuals with diabetes. With minimal training, health care providers can use a special camera to take a picture of the back of the patient's retina, which an algorithm then analyzes to look for the disease. If the software finds evidence of the disease, it recommends that a patient see an eye specialist. A computer program that can analyze medical images could save time and money, cutting down on unnecessary, expensive trips to specialists.

FDA approves AI-powered diagnostic that doesn't need a doctor's help


Marking a new era of "diagnosis by software," the US Food and Drug Administration on Wednesday gave permission to a company called IDx to market an AI-powered diagnostic device for ophthalmology. What it does: The software is designed to detect greater than a mild level of diabetic retinopathy, which causes vision loss and affects 30 million people in the US. It occurs when high blood sugar damages blood vessels in the retina. How it works: The program uses an AI algorithm to analyze images of the adult eye taken with a special retinal camera. A doctor uploads the images to a cloud server, and the software then delivers a positive or negative result.

FDA approves AI-powered software to detect diabetic retinopathy


An additional 84.1 million have prediabetes, which often leads to the full disease within five years. It's important to detect diabetes early to avoid health complications like heart disease, stroke, amputation of extremities and vision loss. Technology increasingly plays an important role in early detection, too. In that vein, the US Food and Drug Administration (FDA) has just approved an AI-powered device that can be used by non-specialists to detect diabetic retinopathy in adults with diabetes. Diabetic retinopathy occurs when the high levels of blood sugar in the bloodstream cause damage to your retina's blood vessels.

FDA approves America's first ever AI medical device that doesn't need a doctor

Daily Mail

US health regulators have approved the first ever artificially intelligent medical device that can identify disease without need for a doctor. The device, called IDx-DR, is designed to detect the most common cause of vision loss among more than 30 million Americans living with diabetes. Its in-built camera takes a picture of the patient's eye, which is assessed by an algorithm to determine whether there are signs of diabetic retinopathy. The move, announced on Wednesday, makes this the first AI device to receive FDA approval to screen without need for a doctor to interpret the results. It means any doctor could use it, including primary care physicians who interact far more frequently with patients with diabetes, rather than patients having to seek out eye doctors themselves.