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.

Scott Gottlieb, commissioner of the Food and Drug Administration, has introduced information technology initiatives under the agency's data science incubator program during the Health Datapalooza conference in Washington, D.C., MedCityNews reported Thursday. Gottlieb highlighted the FDA's Information Exchange and Data Transformation program that seeks to standardize methods to examine potential applications of artificial intelligence in the clinical setting and the use of digital health tools in the premarket drug safety review process. FDA created the INFORMED program with the Innovation, Design, Entrepreneurship and Action laboratory at the Department of Health and Human Services in a move to encourage collaborative scientific research and big data analytics efforts initially related to oncology. The agency partnered with Project Data Sphere to develop algorithms to classify tumor dynamics with the use of medical imaging data and teamed up with the National Cancer Institute to create a fellowship program that aims to produce digital biomarkers. Harvard University and FDA also collaborate on a fellowship program that explores machine learning and AI tools for potential use in the agency's regulatory process.

Digital health tools have and continue to radically change how care is delivered and provided, helping with early detection and cutting costs. Wearable devices, telemedicine and mobile apps already enable patients to be more proactive with their health, and help care providers better tailor individual care. "Artificial intelligence, particularly efforts to use machine learning . . . He spoke April 26 at the Health Datapalooza in Washington, D.C., organized by Academy Health. "We know that to support the widespread adoption of AI tools, we need patients and providers to understand the connection between decision-making in traditional health care settings and the use of these advanced technologies," Gottlieb said.

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.

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. He said the FDA is working with experts to update the way it evaluates these new technologies in the approval process.

TEL AVIV, Israel and NEW YORK and LANCASTER, Pa., April 24, 2018 (GLOBE NEWSWIRE) -- Today, Aspire Universal announced the establishment of the Aspire Ventures Precision Medicine Fund (AVP) to accelerate innovation for personalized devices and medical practices. Precision medicine is one of the most important transformations ever to come to medicine, and by shifting away from one-size-fits-all solutions, precision medicine offers personalized solutions that deliver better experiences and better outcomes at a lower cost. The AVP invests in devices and therapies that leverage AI and IoT to deliver affordable solutions at a massive scale that take into account each individual's DNA, microbiome, biochemistry, and lifestyle. The mission of the AVP is to transform and improve population health by leveraging AI and IoT to develop cutting-edge precision medicine technologies that could have a national, or even global, impact. The fund aims to achieve this goal by greatly accelerating the time-to-market for highly innovative and transformative personalized healthcare solutions – which are the foundation of precision medicine – while maximizing the potential market success rate of those solutions.

Food and Drug Administration Commissioner Scott Gottlieb took aim at various players in the drug supply chain in a Feb. 28 speech, painting a picture of how the system should look. "We want to create a system that flags illegitimate drugs in the supply chain," Gottlieb said. "A fully digitized supply chain can also help develop predictive analytics to reduce health care fraud, waste, and abuse. It can allow regulated industry and regulators to more easily manage or avoid costly or dangerous supply disruptions." As a potential solution to challenges across the system, Gottlieb called for standardized documentation practices for the supply chain as a potential solution -- and that's where technology comes in.

A healthcare provider in Israel has begun to use what its vendor claims is the first-ever artificial intelligence-driven (AI) pathology diagnostic tool to go live in a clinical setting, according to an announcement. Maccabi Healthcare Services, which runs a pathology institute responsible for 160,000 histology accessions every year, recently started leveraging Ibex Medical Analytics' Second Read system, the tech developer said yesterday. The launch came after a pilot period in which the AI tool "identified isolated major errors" regarding prostate core needle biopsies, which were incorrectly diagnosed benign, according to Ibex. Although this is not the first clinical application of AI, Ibex said it is the first in this particular space, helping patients with prostate cancer and adding to a growing portfolio of the technology's diagnostic capabilities. READ: Leo Celi and the'Holy Grail of Personalized Medicine' "We are excited to be the first company to ever deploy an AI-based system in a clinically active pathology lab, leveraging the enormous potential of [AI] to make a real impact on human lives," said Joseph Mossel, MS, co-founder and CEO of Ibex Medical Analytics.

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.

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 will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care."