Optomed - Health technology company

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Here is a list of the currently FDA-cleared camera + AI combinations for retinopathy. Aeye is definitely still the strongest of these; offering both a tabletop camera and a handheld. UMass, for example, took both, and surely many other players will do the same. Each unit gets the device that suits it best. In my opinion, the Aeye-Topcon-Optomed trio is in a very strong position in this market.

Here is the list compiled by Grok:

  1. LumineticsCore (formerly IDx-DR) – Digital Diagnostics
    Camera: Topcon NW400 (TRC-NW400)
    First FDA-autonomous DR system (De Novo 2018)
    Detects more-than-mild diabetic retinopathy (mtmDR)
  2. EyeArt – Eyenuk
    Cameras:
    Canon CR-2 AF
    Canon CR-2 Plus AF
    Topcon NW400
    FDA clearance 2020 (expanded later)
    Detects both more-than-mild DR and vision-threatening DR
  3. AEYE-DS – AEYE Health
    Cameras:
    Topcon NW400
    Optomed Aurora (handheld / portable)
    First FDA-cleared handheld combination (2024)
    Detects more-than-mild diabetic retinopathy
    Requires only 1 image per eye
  4. iPredict-DR – iHealthScreen
    Camera: iCare DRSplus
    More recent clearance (2026)
    Detects more-than-mild diabetic retinopathy
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