FDA accepts new medical device harnessing AI to detect diabetic retinopathy
The US Food and Drug Administration has accepted the marketing of 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. It is the most common cause of vision loss among more than 30mn Americans living with diabetes and is the leading cause of vision impairment and blindness among working-age adults.
“Early detection of retinopathy is an important part of managing care for millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% do not see their eye doctor on a yearly basis,” said Malvina Eydelman, M.D., Director of the Division of Ophthalmic, Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health.
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“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”
The device, IDx-DR, is a software program that uses an artificial intelligence algorithm to analyse images of the eye taken with retinal camera, Topcon NW400. A doctor uploads the digital images of the patient’s retinas to a cloud server on which IDx-DR software is installed.
If images are of sufficient quality, the software provides the doctor with one of two results: (1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or (2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.” If a positive result is detected, patients should see an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.
IDx-DR is the first device authorised for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which importantly, makes it usable by health care providers who may not normally be involved in eye care.
Jvion launches AI-powered map to tackle mental health crisis
Clinical AI company Jvion has launched an interactive map of the US that highlights areas that are most vulnerable to poor mental health.
The Behavioral Health Vulnerability Map uses Jvion's AI CORE™ software to analyse public data on social determinants of health (SDOH) and determine the vulnerability of every US Census block group.
Vulnerability refers to the likelihood that residents will experience issues like self-harm, suicide attempts or overdoses. The map also identifies the most influential social determinants in each region, to show the social and environmental conditions that contribute to mental illness.
As an example, the map shows that Harrison County in Mississippi has a 50% higher suicide rate than the rest of the state. It also shows a high percentage of individuals in the armed forces at a time when active duty suicides are at a six-year high, along with a high prevalence of coronary artery disease, arthritis, and COPD, all chronic illnesses that are linked to a higher suicide risk.
The map also shows Harrison County has a high percentage of Vietnamese Americans, who studies suggest have high rates of depression and may be less likely to seek help from mental health professionals.
The map was built using the same data and analytics that Jvion used to create the COVID Community Vulnerability Map, which was launched towards the start of the pandemic.
With this new map, Jvion is aiming to tackle the growing mental health crisis in the US. “At a time when so many Americans are struggling with their mental health, we’re proud to offer a tool that can help direct treatment resources to the communities that need it most,” said Dr John Showalter, MD, Jvion’s chief product officer, who led the development of the map.
“For too long, the healthcare industry has struggled to address social determinants of health, particularly in the context of behavioural health. Our hope is that by surfacing the social and environmental vulnerabilities of America’s communities, we can better coordinate our response to the underlying conditions that impact the health and wellbeing of people everywhere.”