RetiVue EntireEye Imaging

by RetiVue, LLC  · Based in United States → — See the Entire Eye. Image the Entire World. Ultrawidefield retina imaging from babies to adults. Providing true color, high detail images at a truly affordable price.
Ophthalmology Pediatrics
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Overview

RetiVue, LLC is an early-stage medical technology and services company that manufactures ultrawidefield retinal cameras with automatic image capture. Their mission is to prevent blindness in underserved, medically at-risk populations by creating innovative, affordable products and solutions that aid in the early documentation of eye disease. The company offers both desktop and portable versions of its EntireEye Imaging System, which provides true color, high-detail images with a wide field of view, ranging from 160° on adults to 205° on babies. The technology aims to overcome limitations of existing devices, such as high cost and complex operation, to enable effective deployment of screening services for conditions like retinopathy of prematurity (ROP) and diabetic retinopathy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Early documentation of eye disease
  • Prevention of blindness in underserved populations
  • Screening for retinopathy of prematurity (ROP) in premature infants
  • Screening for potentially blinding eye conditions in healthy newborns (e.g., eye tumors)
  • Screening for diabetic retinopathy
  • Tele-ophthalmic screening in remote locations

What Physicians Need to Know

Retinal Image Analysis (Fundus/OCT)
RetiVue EntireEye Imaging utilizes true color, full-spectrum white light, and non-mydriatic ultra-widefield imaging, capturing up to 205u00b0 field of view with a 20MP 4/3u2033 Sony CMOS sensor. It focuses on fundus photography for a broad overview of the retina, optic nerve, macula, and blood vessels. The system is designed to provide high-definition images that resemble traditional 45u00b0 fundus photos but with a much wider field of view. While the product descriptions emphasize widefield fundus imaging, there is no explicit mention of integrated OCT capabilities within the RetiVue EntireEye device itself for cross-sectional retinal analysis.
Glaucoma Detection
The RetiVue EntireEye system focuses on widefield retinal imaging. Retinal imaging, particularly fundus photography, is crucial for the early detection and monitoring of glaucoma by identifying subtle changes in the optic nerve. However, Optical Coherence Tomography (OCT) is generally considered invaluable for measuring the thickness of the retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC), which are key indicators of glaucoma progression. The available information does not specify if the RetiVue EntireEye system includes OCT for glaucoma-specific structural analysis.
Age-Related Macular Degeneration Screening
Fundus photography, which the EntireEye system provides, is used for baseline documentation and identifying retinal findings. OCT is generally considered best for detecting macular edema and Age-related Macular Degeneration (AMD) by providing detailed cross-sectional images of retinal layers. While teleretinal screening for AMD is promising, further investigation is warranted, with reported sensitivities around 71% and specificities around 88%. The RetiVue EntireEye system's primary focus on widefield fundus imaging suggests its utility for AMD screening would be in identifying visible macular changes rather than detailed structural analysis typically offered by OCT.
Autonomous vs Assistive Diagnosis
The RetiVue EntireEye system features automated focus and capture, and on-screen guided alignment for ease of use. This suggests an assistive role in image acquisition. The company's mission is to provide technology to 'assist ophthalmologic professionals document early eye disease'. There is no explicit mention of autonomous AI-driven diagnostic capabilities for the RetiVue EntireEye system in the provided information. AI-powered retinal cameras can be used autonomously for screening, but their clinical value depends on local validation and integration into care pathways.
Point-of-Care Deployment
The RetiVue EntireEye system is available in both 'Desktop' and 'Portable' versions, designed for ease of use and portability. The portable version is lightweight (1.5 lb handpiece) and comes with a backpack-sized rolling case, making it suitable for various settings. Both versions feature non-mydriatic imaging, automated focus and capture, and on-screen guided alignment, enabling operation by users with varying levels of expertise. This design supports deployment in primary care and underserved communities to improve access to retinal screenings.
Screening Program Integration
RetiVue aims for its products to become the 'de-facto standard equipment used for eye screening'. The EntireEye system's ease of use, affordability, and portability are intended to overcome barriers to effective deployment of screening services, particularly in underserved populations and for conditions like diabetic retinopathy and retinopathy of prematurity (ROP). The Desktop Gen 2.0 model is noted as 'NextGen and Epic EMR and PACS ready with DICOM export', indicating readiness for integration into existing healthcare IT systems. Successful integration of retinal cameras into primary care workflows has been shown to improve access to screenings and early identification of diabetic retinopathy.
Sensitivity & Specificity Data
While RetiVue emphasizes its goal to prevent blindness and improve early documentation of eye disease, specific sensitivity and specificity data for the EntireEye Imaging system for various conditions are not readily available in the provided public information. However, a grant application for the RetiVue WF (likely an earlier or related portable model) mentions a workplan to externally validate that the device has improved sensitivity and specificity for detecting ROP compared to other baby cameras and direct physician exam. General studies on teleretinal screening for diabetic retinopathy report sensitivities ranging from 88% to 91% and specificities from 86% to 95%. For peripheral retinal lesions, ultra-widefield imaging has shown moderate sensitivity (67.4%) and high specificity (98.2%).
FDA De Novo vs 510(k) Pathway
The RetiVue EntireEye system appears to be an innovative retinal imaging technology with a wider field of view than conventional devices. If the technology is truly novel and does not have a legally marketed predicate device with similar technological characteristics and intended use, it would likely pursue the De Novo classification pathway. The De Novo pathway is for novel, low-to-moderate risk devices without a predicate, establishing a new classification and allowing the device to serve as a predicate for future 510(k) submissions. The 510(k) pathway requires demonstrating substantial equivalence to an existing predicate device. Given RetiVue's claims of revolutionary design and imaging capabilities, a De Novo pathway might be more appropriate if it introduces new questions of safety and effectiveness not addressed by existing predicates.
Physician Tip

Leverage the ultra-widefield, non-mydriatic imaging capabilities of the RetiVue EntireEye for efficient and comprehensive retinal screening in diverse patient populations, including premature infants and adults. The portability of the device makes it ideal for outreach programs and point-of-care settings, potentially increasing screening rates for conditions like diabetic retinopathy and ROP. While excellent for documenting visible retinal pathology, consider supplementary OCT imaging for detailed structural analysis in cases of suspected glaucoma or macular degeneration, as the EntireEye primarily offers fundus photography. Utilize the automated features for consistent image quality, even with less experienced operators, and integrate with EMR/PACS for streamlined workflow and patient record management.

The RetiVue EntireEye Desktop Gen 2.0 is designed to be 'NextGen and Epic EMR and PACS ready with DICOM export'. This indicates direct compatibility with major electronic medical record and picture archiving and communication systems, facilitating seamless integration into existing clinical workflows for image storage, retrieval, and sharing. The ability to export in DICOM format ensures interoperability with various ophthalmic imaging and viewing platforms.

Details

Category Ophthalmology AI, Radiology & Imaging AI
Pricing Paid
  • EntireEye Desktop Gen 2.0: $12,995.00; Adult Model Eye Kit: $795.00; Extra Lens Module: $1,395.00; 12V in /9V out Lithium Battery: $95.00; 12V Lithium Battery: $99.00
DeploymentOn-premise (device-based)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated — unknown
Integrations
EHR Not specified
Specialties Ophthalmology, Pediatrics

What the Web Says

RetiVue EntireEye Imaging offers both desktop and portable ultra-widefield retinal cameras designed for true-color, high-definition imaging of the retina in patients ranging from babies to adults. The system aims to provide affordable and easy-to-use technology to aid in the early detection of eye diseases like retinopathy of prematurity and diabetic retinopathy, particularly in underserved populations.

Overall: Mixed

Strengths

  • True-color, full-spectrum white light imaging.
  • Non-mydriatic (no pupil dilation required) operation with a minimum pupil size of 3.0mm.
  • Ultra-widefield imaging, with up to 205u00b0 field of view on the portable model for babies.
  • High-resolution 20MP Sony CMOS sensor for detailed images.
  • Automated focus and capture with on-screen guided alignment for ease of use.
  • Portable and lightweight design with EMR/PACS readiness and DICOM export.

Limitations

  • Earlier iterations of the technology required multiple images to capture the entire retina and direct contact with the eye for the widest field of view.
  • General concerns exist within the optometry community about widefield fundus photos being presented as a substitute for a dilated fundus exam, though this is not specific to RetiVue.
  • Some portable retinal cameras, in general, may have image quality and field of view inferior to standard fundus cameras, and stability can be an issue.
  • No specific physician, healthcare IT, or tech reviewer opinions or reviews were found for RetiVue EntireEye Imaging on G2, Capterra, or Reddit.
  • Cost of the device, while stated as affordable by RetiVue, is not explicitly detailed in the search results, making it difficult to assess against competitors.
  • Lack of independent reviews from physicians or tech reviewers makes it difficult to gauge real-world performance and user satisfaction.

Based on reviews from: RetiVue, LLC, NIH RePORTER, OpenGrants, Review of Ophthalmology, ResearchGate, Reddit

Last updated: 2026-09-10

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Press & Coverage

RetiVue, LLC
The RetiVue System travels with FOCUS to Haiti
RetiVue's EntireEye system was deployed to Haiti with FOCUS to test its capabilities with darkly-pigmented eyes, demonstrating its potential in diverse populations.
2025-11
RetiVue, LLC
The RetiVue EntireEye Camera Captures Eyecare Success in Panama
RetiVue partnered with FANLYC in Panama, providing its EntireEye WideField Portable Retina Camera to enhance eyecare for patients.
2025-11
RetiVue, LLC
RetiVue successfully demonstrates recent advances in its imaging solutions at the American Academy of Ophthalmology and American Optometric Association annual meetings.
RetiVue showcased its latest advancements in imaging solutions at major ophthalmology and optometry conferences in October 2024.
2024-10
RetiVue, LLC
RetiVue receives a Phase I NIH SBIR thru the NEI to develop a highly novel 3D endoscopy solution for vitreoretinal surgery.
RetiVue secured a Phase I NIH SBIR grant to develop an innovative 3D endoscopy solution for vitreoretinal surgery.
2024-05
NIH RePORTER
RetiVue WF - A Handheld, High-Resolution, Widefield Retinal Imager
This NIH project details the development of the RetiVue WF, an affordable, easy-to-use baby camera designed for high-resolution, wide-field retinal imaging to screen for Retinopathy of Prematurity (ROP) and other eye diseases in newborns.
unknown
Facebook (RetiVue)
RetiVue has touched down in Salt Lake City, Utah, for #AAPOS2025
RetiVue showcased its EntireEye Portable and Premature Infant Training Kit at the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2025 meeting.
2025-03
JMIR Formative Research
Performance of a Retinal Imaging Camera With On-Device Intelligence for Primary Care: Retrospective Study
This study evaluates the Verily Numetric Retinal Camera (VNRC), a nonmydriatic, 45u00b0 field imaging system, demonstrating its high performance and usability for diabetic retinopathy screening in primary care settings.
2025-07
MDPI
Retinal Imaging-Based Oculomics: Artificial Intelligence as a Tool in the Diagnosis of Cardiovascular and Metabolic Diseases
This article explores the use of AI-driven analysis of retinal images (oculomics) as a non-invasive and cost-effective approach for early detection and risk assessment of cardiovascular and metabolic diseases.
2024-09

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Suggest an Edit → | Last Verified: 2026-09-10 | First Added: 2026-09-10
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