Breaking News
September 25, 2018 - New program to reduce harmful stress effectively improves mood in cancer patients
September 24, 2018 - Florence’s Lingering Threat: Mold – Drugs.com MedNews
September 24, 2018 - For professional baseball players, faster hand-eye coordination linked to batting performance
September 24, 2018 - Bill for later school start times is defeated, but Stanford sleep specialist isn’t
September 24, 2018 - For Heart Failure Patients, Mitral Valve Procedure Improved Outcomes
September 24, 2018 - Successful recovery from addiction means more than achieving abstinence
September 24, 2018 - New nanoplatform technology may reverse drug-resistance in renal cell carcinoma
September 24, 2018 - October 1918 marks the centenary of Spanish Flu that claimed more lives than World War I
September 24, 2018 - LGBT community reports more number of poor mental health days than general population
September 24, 2018 - New research suggests power of zebrafish as tool for cancer drug discovery
September 24, 2018 - New study finds height as possible risk factor for developing varicose veins
September 24, 2018 - Researchers compare weight loss results of online and in-person diabetes prevention program
September 24, 2018 - New HER2 PET Study Uses Affibody’s ABY-025 Tracer to Individualize Breast Cancer Treatment
September 24, 2018 - Drug combination offers more effective care for patients suffering miscarriage
September 24, 2018 - Tallness linked to varicose veins, Stanford study says
September 24, 2018 - For Heart Failure Patients, Mitral Valve Procedure Improved Outcomes
September 24, 2018 - Ecstasy drug makes octopuses more social
September 24, 2018 - Immediate compression therapy could cut risk of complications after deep-vein thrombosis
September 24, 2018 - Transcatheter mitral valve repair reduces mortality for patients with mitral regurgitation
September 24, 2018 - First intracranial aneurysm patients treated with BRAVO Flow Diverter after CE mark approval
September 24, 2018 - ‘Physicians of the mouth’? Dentists absorb the medical billing drill
September 24, 2018 - People more likely to believe those with confident tone of voice than with accent
September 24, 2018 - Harmony Biosciences Presents 5-Year Data On Pitolisant At International Narcolepsy Symposium
September 24, 2018 - Blood test may identify gestational diabetes risk in first trimester
September 24, 2018 - Height may be risk factor for varicose veins | News Center
September 24, 2018 - King’s commemorates opening of new NMR facility with one-day symposium
September 24, 2018 - Eisai receives approval for partial label change of DC Bead device for transcatheter arterial embolization
September 24, 2018 - High-resolution genomic map gives scientists unprecedented view of brain development
September 24, 2018 - Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD
September 24, 2018 - First evaluation of benefits, harms of Alzheimer’s screening for family members of older adults
September 24, 2018 - Ancora Heart announces positive data of study evaluating AccuCinch Ventricular Repair System
September 24, 2018 - Children of mothers using cannabis may start using it at an earlier age, finds study
September 24, 2018 - Gilead Sciences plans to launch authorized generic versions of Epclusa and Harvoni in the US
September 24, 2018 - Most patients who underwent transcatheter valve replacement experience prosthesis-patient mismatch
September 24, 2018 - Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone
September 24, 2018 - New study provides basis for Air Canada to change its facial hair policy for aircrew
September 24, 2018 - Infant walkers lead to thousands of emergency visits for babies
September 24, 2018 - Genes predicting person’s height may provide clues about causes of varicose veins
September 24, 2018 - EPA Plan Will Maintain Carbon Emissions From Power Plants
September 24, 2018 - Characterizing pig hippocampus could improve translational neuroscience
September 24, 2018 - Element3 Health reports social and mental engagement play key role in overall health
September 24, 2018 - Paralympic medalists support Fight for Sight’s unique virtual event
September 24, 2018 - ADCETRIS drug receives approval in Japan as frontline treatment option for Hodgkin lymphoma
September 24, 2018 - Public awareness of urological conditions found to be alarmingly low across Europe
September 24, 2018 - Fitter Folks Suffer Milder Strokes: Study
September 24, 2018 - Novel botulinum toxin compound relieves chronic pain
September 24, 2018 - CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents
September 24, 2018 - National Friendly’s private medical insurance is a hit with women living in the South East
September 24, 2018 - Academics receive prestigious awards for achievements in blood pressure research
September 24, 2018 - Obese pregnant women can restrict weight gain safely with proper nutrition guidance
September 24, 2018 - CHMP adopts positive opinion of Takeda’s ALUNBRIG for treatment of ALK+ non-small cell lung cancer
September 24, 2018 - China NMPA approves LENVIMA for treatment of unresectable hepatocellular carcinoma
September 24, 2018 - A new approach for finding Alzheimer’s treatments
September 24, 2018 - USC research uncovers previously unknown genetic risk factor for dementia
September 24, 2018 - Study examining mental health among students finds significant disparities in treatment across race
September 24, 2018 - Breakthrough discovery paves way for future test to identify drowsy drivers
September 24, 2018 - Transcatheter mitral-valve repair in patients with heart failure
September 24, 2018 - Study opens new avenues for treatment of Laing distal myopathy
September 24, 2018 - Stroke Facts | cdc.gov
September 24, 2018 - Sarcolipin tricks muscle cells into using more energy, burning fat
September 24, 2018 - Enrollment in opioid controlled substance agreement reduces primary care visits
September 24, 2018 - UTA researchers patent new smart seat cushion technology that helps prevent painful ulcers
September 24, 2018 - Second HPV-Related Primary Cancers Common in Survivors
September 24, 2018 - How a virus destabilizes the genome
September 24, 2018 - Old letters provide insight into Spanish flu pandemic horror
September 23, 2018 - Smart textile-based soft robotic exosuit helps wearers save energy and traverse difficult terrain
September 23, 2018 - New research hub to drive radical change in development and manufacturing of vaccines
September 23, 2018 - AHA: For Hispanics, Neighborhood May Be Key Factor in Heart Disease Risk
September 23, 2018 - Excessive airway nerves tied to more severe asthma symptoms, study finds
September 23, 2018 - Study highlights need to remain vigilant in maintaining key infection control processes
September 23, 2018 - Novel therapeutic strategy for blood vessel related disorders, such as cancer and retinopathy
September 23, 2018 - New naturally occurring antibiotic found effective against Mycobacterium tuberculosis
September 23, 2018 - First-in-human phase 0 study shows clinically-relevant activity of new drug in glioblastoma
September 23, 2018 - Removing tobacco product display from shops reduced number of children buying cigarettes
September 23, 2018 - Random fraction of specialized immune cells leads the charge in battling invaders
September 23, 2018 - Few minutes of sprinting exercise may be as effective as longer exercise sessions
September 23, 2018 - Researchers use neutrons to make first direct observations of water in lipid bilayers
September 23, 2018 - Researchers demonstrate pre-clinical success for universal flu vaccine in new paper
September 23, 2018 - Study reveals surprising gaps in some HIV medical providers’ knowledge of ACA
September 23, 2018 - Oxehealth secures European medical device accreditation for vital signs measurement software
FDA authorizes marketing of first AI device to detect diabetic retinopathy

FDA authorizes marketing of first AI device to detect diabetic retinopathy

image_pdfDownload PDFimage_print

The U.S. Food and Drug Administration today permitted 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. 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 percent of them do not see their eye doctor on a yearly basis,” said Malvina Eydelman, M.D., 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.”

The device, called IDx-DR, is a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the 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 the 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 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 evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. The study was designed to evaluate how often IDx-DR could accurately detect patients with more than mild diabetic retinopathy. In the study, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 percent of the time.

Patients who have a history of laser treatment, surgery or injections in the eye or who have any of the following conditions should not be screened for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. IDx-DR should not be used in patients with diabetes who are pregnant; diabetic retinopathy can progress very rapidly during pregnancy and IDx-DR is not intended to evaluate rapidly progressive diabetic retinopathy. IDx-DR is only designed to detect diabetic retinopathy, including macular edema; it should not be used to detect any other disease or condition. Patients will still need to get a complete eye examination at the age of 40 and at the age of 60 and also if they have any vision symptoms (for example, persistent vision loss, blurred vision or floaters).

IDx-DR was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. IDx-DR was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

The FDA is permitting marketing of IDx-DR to IDx LLC.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604357

Tagged with:

About author

Related Articles