Artificial Intelligence in Medicine.

NH Health Watch Articles: FDA Approves First AI Device.


FDA Approves First AI Device
Device detects greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.

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 US FDA just approved the marketing of the first AI medical device. 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.


Posted 4/11/18

 

Scheduled Events

  Seussical   (9/6-15)
  2001 Space Odyssey   (9/7)
  Muster in the Mountains   (9/7-9)
  Wingzilla   (9/8)
  Canzoniere Grecanico Salentino   (9/9)
  Things [Mom] Taught Me   (9/13-23)
  Reach the Beach   (9/14-15)
  WM Storytelling Festival   (9/14-16)
  Metallak Race   (9/15)
  Mandeville & Richards   (9/15)
  Cohase Film Slam   (9/16)
  Tricycle Grand Prix  (9/16)
  Rodney Crowell   (9/21)
  NH Highland Games   (9/21-23)
  Don Who   (9/22)
  Harvest Celebration   (9/22)
  Health & Wellness Fair   (9/22)
  Jeep Invasion  (9/22)
  Lakes Region Tri Festival   (9/22-23)
  Pat Metheny   (9/26)
  Driving Miss Daisy   (9/27 - 10/6)
  Neko Case   (9/27)
  Shot of JD   (9/28)
  Dixville Half Marathon   (9/29)
  New Hampshire Marathon   (9/29)
  Matthew Odell   (9/30)
  Lincoln Fall Craft Festival   (10/6&7)
  Sparrow Blue & Crowes Pasture   (10/6)
  Oktoberfest  (10/6-7)
  White Mountain Oktoberfest   (10/6-7)
  Fall Foliage Celebration   (10/6-8)
  Sandwich Fair   (10/6-8)
  Paddle the Border   (10/7)
  Lincoln Fall Craft Festival   (10/7-9)
  Shadow Play   (10/10)
  Killer Joe   (10/11-21)
  Greg Brown   (10/12)
  Camping & RV Show   (10/12-14)
  Riverfire & Horrorfest   (10/13)
  Jay Stollman Band   (10/19)
  Murder Dinner Train   (10/19-20)
  Pumpkin Patch Express   (10/19-21)
  All Things Pumpkin   (10/20)
  Ethan Setiawan Band   (10/20)
  Bettye LaVette   (10/26)
  Murder Dinner Train   (10/26-27)
  Pumpkin Patch Express   (10/26-28)
  Berlin Jazz   (10/27)

 ◄ Expanded Calendar ►



Photo Galleries

 

Miss Berlin-Gorham Competition 2012 New England Brewfest 2014 RiverFire, Berlin, NH 2012 Sugar Hill Lupine Festival Gallery 2012 Bristol-Gorham Foliage
Quick Links

 






Business Directory

 

 

                      more ►  

 

 

Attractions

 


Area Attractions opening/closing schedules.


  Alpine Adventures
  Clark's Trading Post
  Cog Railway
  Conway Scenic Railroad
  Flume
  Fort Jefferson Fun Park
  Jericho Mountain ATV Park
  Kancamagus Highway
  Littleton Riverwalk
  Lost River Gorge
  Mountain Meadow Funplex
  Mt. Washington Auto Road
  Polar Caves
  Santa's Village
  Storyland
  Vertical Ventures
  Whale's Tail Water Park
  Woodstock Inn & Brewery

 

more ►  

 

Community Profiles

 

  Bethlehem
  Bretton Woods
  Colebrook
  Conway
  Franconia
  Gorham
  Hanover
  Jackson
  Lebanon
  Lincoln
  Littleton
  North Conway
  Pittsburg
  Plymouth
  Twin Mountain
  Whitefield
  Wolfeboro

more ►  

 

Recreation and Tourism

 

  25 Great Summer Adventures
  Farm To Table Restaurants
  Hiking To Crash Sites
  Little Ski Areas
  Local Movie Theaters
  Local Performance Theaters
  Moose Tours

 

more ►  

 

Other Resources

  NH Cabins & Cottages
  NH Census Info
  NH Data (OEP)
  NH Fishing Reports
  NH Foliage Report
  NH Hiking Trail Conditions
  NH Lottery
  NH Movie Guide
  NH Road Conditions
  NH Ski Reports
  NH Snowmobile Trail Reports
  NH State Parks
  NH Town Officials Directory
  NH Weather
  Summer Safety Tips [.pdf]
  White Mtn. National Forest
  VisitNH.Gov

 

 

 

Copyright 2012-2018 by George C. Jobel, 603-491-4340. All Rights Reserved.