IDx-DR autonomous diabetic retinopathy detection

entry · p2026-09-06-080 · validated

A total of 900 participants were enrolled at 10 sites, of which 892 participants completed all procedures

tech: idx-dr
passes the definition as: a convolutional-network diagnostic pipeline fit to retinal images, making a diagnosis without a clinician reading the image
from: 2018-04-11
region: US
domain: health
side: benefit
people: 900 patients (2018-08-28)
effect: 87.2 percent sensitivity (2018-08-28) — sensitivity for more-than-mild diabetic retinopathy (specificity 90.7%) in primary care, no ophthalmologist in the loop
reversible: yes
who holds the switch: owner:Digital Diagnostics (IDx), under FDA authorisation
attribution: named
source kind: primary
the statistic: The pivotal trial enrolled 900 patients at 10 primary care sites; 819 were fully analysable, giving 87.2% sensitivity and 90.7% specificity. FDA authorised the device on 11 April 2018 as the first autonomous AI diagnostic.
source: https://pmc.ncbi.nlm.nih.gov/articles/PMC6550188/
proposed by: researcher (opus), brief 2026-09-06, era-2012-2019
received: 2026-09-06T09:39:39-04:00
harvest report: impacts/harvest/2026-09-06-era-2012-2019.md

Rulings, in order

2026-09-06T09:39:47-04:00 · validatorpass — quote found on the fetched page (exact match; HTTP 200 text/html; charset=utf-8)
2026-09-06T09:59:36-04:00 · sessionseverity — a diagnosis in service without a specialist

The proposal as it arrived (JSON)

{
 "id": "p2026-09-06-080",
 "received": "2026-09-06T09:39:39-04:00",
 "proposer": "researcher (opus), brief 2026-09-06, era-2012-2019",
 "kind": "entry",
 "sha": "c80f2d470c289dc7",
 "data": {
  "kind": "entry",
  "tech": "idx-dr",
  "tech_name": "IDx-DR autonomous diabetic retinopathy detection",
  "definition": "a convolutional-network diagnostic pipeline fit to retinal images, making a diagnosis without a clinician reading the image",
  "from": "2018-04-11",
  "region": "US",
  "domain": "health",
  "side": "benefit",
  "people": {
   "n": 900,
   "unit": "patients",
   "date": "2018-08-28"
  },
  "effect": {
   "n": 87.2,
   "unit": "percent sensitivity",
   "date": "2018-08-28",
   "what": "sensitivity for more-than-mild diabetic retinopathy (specificity 90.7%) in primary care, no ophthalmologist in the loop"
  },
  "reversible": true,
  "switch": "owner:Digital Diagnostics (IDx), under FDA authorisation",
  "statistic": "The pivotal trial enrolled 900 patients at 10 primary care sites; 819 were fully analysable, giving 87.2% sensitivity and 90.7% specificity. FDA authorised the device on 11 April 2018 as the first autonomous AI diagnostic.",
  "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC6550188/",
  "quote": "A total of 900 participants were enrolled at 10 sites, of which 892 participants completed all procedures",
  "attribution": "named",
  "source_kind": "primary"
 },
 "from_file": "impacts/harvest/2026-09-06-era-2012-2019.md"
}