*mymedicalexpo

Retinal camera
hand-held

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Characteristics

Overview

Handheld fundus camera designed for non-mydriatic, high-resolution digital fundus imaging in clinical and point-of-care environments.
Autofocus and autoexposure functions reduce setup time and simplify image capture.
Cloud connectivity enables secure transfer of images for remote review and AI analysis.

AI-Powered Diagnostic Service

Cloud-based artificial intelligence service analyzes fundus images to identify more-than-mild diabetic retinopathy (MTM-DR).
Provides real-time results based on a single image per eye to support screening workflows.
Designed for integration with clinical systems and telemedicine services.

User Management Portal

Secure web portal for account registration, user management and role-based access control.
Allows access to diagnostic reports and exports results in PDF format for clinical records.

Performance and Clinical Validation

FDA-cleared device with clinical validation studies supporting diagnostic performance.
Reported sensitivity and specificity greater than 90% for diabetic retinopathy detection in validation cohorts.
Delivers on-the-spot results in under 60 seconds using one image per eye without pupil dilation.

Commercial & Operational Features

Technical specifications

Device type: Handheld fundus camera
Imaging mode: Non-mydriatic, digital fundus imaging
Optical features: Autofocus and autoexposure
Connectivity: Cloud-based AI integration and secure image transfer
AI capability: Real-time analysis for detection of more-than-mild diabetic retinopathy
Image requirement: Single image per eye
Result time: Under 60 seconds
Regulatory status: FDA-cleared; clinically validated
Clinical performance: Reported >90% sensitivity and specificity
Reimbursement: CPT code 92291 indicated
Commercial terms: No startup costs; fixed monthly subscription