AI directory

This AI directory is a a free and useful resource that the College has created for clinicians, commissioners, vendors, researchers and anyone with an interest in AI.

Introducing the AI directory

This is a free and useful resource that the College has created for clinicians, commissioners, vendors, researchers and anyone with an interest in artificial intelligence (AI).

We have developed the directory because we believe that AI has the potential to have a profound impact on the science and practice of ophthalmology. 

Comprising information published by vendors and academic sources, the AI directory shows at-a-glance artificial intelligence as a medical device (AIaMD) tools that have contributed to the specialty in the UK. It does not recommend specific vendors or their products, or draw any comparisons between devices.*

Why do we need an AI directory?

The use and influence of AI will continue to expand as the technology develops and more AIaMD tools are adopted for clinical, research and administrative use. Our AI directory will capture this development and growth. Currently, no AIaMD tools have been rolled out across NHS ophthalmology departments: their use is localised or has contributed to studies and research, and some tools have been tested in pilot form. It is strongly anticipated that in time devices will become patient-facing. 

How will ophthalmology lead the way in AI adoption?

Ophthalmology is an image-focused specialty, and so AI is playing an increasingly important role in diagnostics. Datasets such as multiple retinal scans that ophthalmologists rely on for making a diagnosis and developing a treatment plan readily lend themselves to the training of AI algorithms. 

Addressing concerns about the role of AI in ophthalmology 

As we outline in our AI position statement, AI will not replace doctors, but time-saving tools support efficiency improvements. Globally, AI has the potential to offer health providers scalable solutions for screening and diagnosis, which should speed up patient waiting times and streamline referral to treatment pathways. However, AIaMD tools should be developed, validated and deployed across a fully diverse patient population to ensure that their use in clinical and diagnostic settings minimises the risk of exacerbating health inequities. Clear patient guidelines on data usage and sharing are also essential.

AI directory

Welcome to the AI directory for ophthalmology. Click on the AIaMD tools to see more details.

Overview

  1. Product Name: Altris AI
  2. Product version: NA
  3. Input data: All OCT manufacturers device with Dicom export (Topcon, HE, Optopol, Optovue, Zeiss, etc)
  4. Regulatory approval: CE class IIa MDR
  5. Intended use: Decision support for Ophthalmology for screening and pathology/treatment progression analysis with quantitative data for over 70 retinal pathologies and biomarkers
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/124973

Deployment in the NHS

  1. Routine clinical use (Y/N): Y Within clinical research (Aston University, UHB)
  2. Pilot (Y/N): N
  3. Clinical research:

  1. Product Name: AutoGrader (formerly iGradingM)
  2. Product version: 1.1
  3. Input data: Episode ID and associated retinal images sent via SOAP interface from Scottish Diabetes Eye Screening IT System (currently NEC OptoMize). Fundus camera is an optional input
  4. Regulatory approval: UKCA Class IIa, current status = ‘Pre-certificate”
  5. Intended use: AutoGrader is a Software as a Medical Device (SaMD) Automated Image assessment tool with the intended purpose of identifying images with microaneurysms , a diagnostic feature of Diabetic Retinopathy, in patients aged 12 and older, that have been previously diagnosed with Diabetes. The AutoGrader component is a stand-alone SaMD, retinal image analysis application.
  6. MHRA PARD: No listing

Deployment in the NHS

  1. Routine clinical use (Y/N):  Y Deployed centrally accepting data from the National DES IT System, OptoMize, which is used in all 14 Scottish Health Boards.
  2. Pilot (Y/N): N
  3. Clinical research:
    https://bjo.bmj.com/content/91/11/1512 https://pmc.ncbi.nlm.nih.gov/articles/PMC2095413/ https://pubmed.ncbi.nlm.nih.gov/20858722/

Overview

  1. Product Name: BioAge
  2. Product version:
  3. Input data: Retinal fundus photographs from Topcon NW400, NW500, Maestro 1, Maestro 2, Optos California and Daytona
  4. Regulatory approval: CE class I
  5. Intended use: Estimates biological age from retinal images through analysis of vascular and metabolic indicators as a non‑invasive biomarker for overall health
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/110764

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research: Study conducted using data from UK Biobank, https://pubmed.ncbi.nlm.nih.gov/38935034/

Overview

  1. Product Name: EyeArt
  2. Product version: 3.0
  3. Input data: Retinal images from fundus cameras from manufactures including Canon, iCare, Nidek, Optomed, Topcon, and Zeiss.
  4. Regulatory approval: CE class IIb
  5. Intended use: Detect signs of diabetic retinopathy (including diabetic macular edema), age-related macular degeneration (AMD), and glaucomatous optic nerve damage using computerized analysis of images of the retina.
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/125344

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): Y DESPs (Diabetic Eye Screening Programmes) in North East London (NEL), South East London (SEL) and Gloucestershire (GS). https://assets.publishing.service.gov.uk/media/60a28822e90e07356e2bbc40/AI_in_DESP_Rapid_review_consultation_2021.pdf
  3. Clinical research: https://pubmed.ncbi.nlm.nih.gov/32606081/; https://pubmed.ncbi.nlm.nih.gov/31335200/; https://pubmed.ncbi.nlm.nih.gov/34779843/; https://pubmed.ncbi.nlm.nih.gov/36345378/

Overview

  1. Product name: iCare RETCAD
  2. Product version: 3.0.3
  3. Input data: Color fundus image in the RGB color space taken at an angular resolution between 30 and 50 degrees and having even illumination across the retina. Input image file formats: .png, .jpg, .jpeg, .tif, .dcm or .bmp, in case of a single image input. For multiple inputs, .dcm file format.
  4. Regulatory approval: CE class IIa
  5. Intended use: Analyses colour fundus retinal images to provide results for clinical decision support relating to Age-related Macular Degeneration, Diabetic Retinopathy and Glaucoma. Heatmaps highlight abnormalities detected.
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/45627

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): Y Southend Hospital, NHS Northwest London screening programme
  3. Clinical research: https://onlinelibrary.wiley.com/doi/10.1111/dme.15055

Overview

  1. Product Name: Medios AI by Remidio
  2. Product version:
  3. Input data: Fundus images via Remidio FOP NM‑10 or desktop cameras
  4. Regulatory approval: CE class IIb
  5. Intended use: Offline screening for referable diabetic retinopathy
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/42281

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research: https://pmc.ncbi.nlm.nih.gov/articles/PMC10619585/; https://pmc.ncbi.nlm.nih.gov/articles/PMC7003589/; https://www.nature.com/articles/s41433-023-02826-z

Overview

  1. Product Name: Reti-CVD
  2. Product version:
  3. Input data: Compatible with most fundus cameras
  4. Regulatory approval: CE class IIa
  5. Intended use: Risk stratification for future cardiovascular disease
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/51917

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research: Use of clinical data and retinal photographs from the UK Biobank https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02684-8

Overview

  1. Product Name: Reti-Eye
  2. Product version:
  3. Input data: Compatible with most fundus cameras
  4. Regulatory approval: CE class IIa
  5. Intended use: Screening for ocular diseases (DR, AMD, glaucoma, cataract)
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/51917

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research:

Overview

  1. Product name: RetinAI Discovery for Clinics
  2. Product version: Discovery Clinics v.5.3
  3. Input data: OCT, OCT-A, fundus cameras providing DICOM images including HDE, TopCon, Zeiss, Nidek, Nikon
  4. Regulatory approval: CE class IIa
  5. Intended use: Gathers biomarker and clinical endpoint data on OCT and fundus images. Detects presence or absence of 13 retinal biomarkers, layers & fluid (SRF, IRF, HF, RPE, PR, Drusen, RPD, ERM, GA, ORA, FPED).
  6. MHRA PARD: No listing

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): Y Led by Neil Bowley, consultant ophthalmologist at Royal Devon NHS trust Exeter
  3. Clinical research: https://journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-025-00634-z;
    https://link.springer.com/article/10.1186/s40942-025-00665-6

Overview

  1. Product Name: RetinaLyze
  2. Product version: 4.5.4
  3. Input data: Retinal images (10-200 degrees) and OCT scans (macula)
  4. Regulatory approval: CE Class 1 (MDD) with application for Class IIa approval
  5. Intended use: Investigation and identification of pathological changes in the retina and optic nerve head.
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/109488

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research: https://www.retinalyze.com/research; https://www.nice.org.uk/advice/mib265/resources/ai-technologies-for-detecting-diabetic-retinopathy-pdf-2285965755558853

Overview

  1. Product Name: RetInSight Fluid Monitor
  2. Product version: 4.3.0
  3. Input data: OCT image uploaded from a Heidelberg Engineering ‘Spectralis’ via the HEYEX PACS system to RetInSight using a cloud-based system for analysis, producing PDF report.
  4. Regulatory approval: CE class IIa – (MDR 2017/745)
  5. Intended use: For use in clinical routine. Visualize retinal fluid types and location automatically. Accurately measure fluid-related biomarkers, including intraretinal fluid (IRF), subretinal fluid (SRF) and pigment epithelial detachment (PED) in real-time with nanoliter precision. Visualize and track disease progression.
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/103920

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research:

Overview

  1. Product Name: RetInSight GA monitor
  2. Product version: 1.2.1
  3. Input data: OCT image uploaded from Heidelberg Engineering ‘Spectralis’ via the HEYEX PACS system to RetInSight using a cloud-based system for analysis, producing PDF report.
  4. Regulatory approval: CE class IIa
  5. Intended use: For use in clinical routine. Measure and visualize disease activity and therapeutic efficacy across all aspects, including photoreceptor (PR) degeneration, retinal pigment epithelium (RPE) loss2 consistent with FAF and the PR/RPE overlap providing insight into progression and therapeutic response.
  6. MHRA PARD: https://pard.mhra.gov.uk/manufacturer-details/103920

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research:

Overview

  1. Product Name: Retmarker System
  2. Product version: 2.0
  3. Input data: Traditional fundus cameras
  4. Regulatory approval: CE Class-IIa
  5. Intended use: Support in the screening and the management of retinal diseases based on digital images acquired by fundus cameras
  6. MHRA PARD: No listing

Deployment in the NHS

  1. Routine clinical use (Y/N): N
  2. Pilot (Y/N): N
  3. Clinical research: Official studies led by Prof. Adnan Tufail from Moorfields https://ai.nejm.org/doi/10.1056/AIoa2400353; https://pubmed.ncbi.nlm.nih.gov/27981917/

How the AI directory may expand 

The first iteration of the AI directory contains AIaMD tools that are intended for a clinical or research setting and that are powered by diagnostics and treatment-based AI. AI will also advance the science of ophthalmology by streamlining processes for researchers, such as those who work in an ophthalmic reading centre. These AI-powered tools are deployed for image grading and analysis, with an algorithm able to analyse many images faster and more accurately than the human eye. Other digital health technologies may use AI for administrative purposes. Uses include triaging outpatients for follow-up appointments and automatically writing up patient notes for doctors from voice recordings. Such devices are not AIaMD so have not been considered for this iteration of the Directory. See ‘Machine Learning-enabled Medical Devices: Key Terms and Definitions‘ by the International Medical Device Regulators Forum (IMDRF) for a definition of ‘medical device’.    

Further resource – the AI and Digital Regulations Service (AIDRS)

The AI Directory may be of interest to vendors, developers and innovators. The products listed within the directory have been through a procurement process and received regulatory approval. This can be a long and complicated process to navigate. The AI and Digital Regulations Service (AIDRS) is a free resource that is a collaboration between NHS Health Research Authority, NICE, MHRA and CQC. It has separate channels of guidance for both developers and adopters, walking them through every step of the process.

*Disclaimer

The Royal College of Ophthalmologists’ AI directory lists AIaMD tools that have been or are being used in NHS ophthalmic research or practice. The directory does not recommend specific vendors or their products, or draw any comparisons between devices. The College strives to keep the directory accurate and up to date, but it may not be possible to capture every AIaMD as soon as it has been applied in ophthalmology. We cannot guarantee that the resource is free from error or omission.

We invited AI software vendors to contribute details of their AIaMD tools, and we created listings for eligible devices. We welcome the provision of details in the above format from vendors who consider their AIaMD products meet the above criteria for inclusion in a future update. Contact [email protected] with any queries about the AI directory.

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