Medical Disclaimer

1. Not a Substitute for Professional Medical Advice

The information, analysis, and outputs provided by the ProdigEye platform are intended solely to assist licensed healthcare professionals in their clinical decision-making process. They do not constitute medical diagnoses, prescriptions, or treatment plans.

All clinical decisions, including diagnosis, treatment, referral, and patient management, must be made by a qualified and licensed medical practitioner based on their professional assessment of the individual patient, their full medical history, and all relevant clinical findings.

2. Limitations of AI-Based Analysis

ProdigEye's AI diagnostic outputs are based on pattern recognition from a validated clinical dataset. Users must be aware of the following limitations:

• Performance may vary depending on image quality, lighting conditions, and camera specifications
• The AI system has been validated on specific patient populations and may perform differently on underrepresented demographics
• The system is designed specifically for anterior segment conditions and should not be used for other ophthalmic or medical conditions
• Preliminary validation metrics (97.4% sensitivity, 97.5% specificity) are based on an internal dataset of 76 images and may not reflect real-world performance across all clinical settings
• Edge cases, atypical presentations, and rare conditions may not be reliably identified

3. Regulatory Status

ProdigEye is developed as a Software as a Medical Device (SaMD) in accordance with applicable regulatory frameworks. Users should be aware that:

• The platform is currently in the clinical validation and regulatory submission phase
• It has not yet received CE marking under EU MDR 2017/745 or FDA clearance/approval
• Use outside of approved clinical investigation or research contexts may be subject to local regulatory restrictions
• Healthcare institutions are responsible for ensuring compliance with their own regulatory and institutional requirements before deploying this tool

4. No Doctor-Patient Relationship

Access to and use of the ProdigEye website and platform does not create a doctor-patient relationship between ProdigEye Ltd. and any end patient. ProdigEye Ltd. is a technology company, not a healthcare provider.

Patients should always consult a qualified healthcare professional for any medical concerns. If a patient believes they have a medical emergency, they should contact emergency services immediately.

5. Indemnification

Healthcare professionals and institutions using the ProdigEye platform agree to indemnify and hold harmless ProdigEye Ltd. and its officers, directors, employees, and agents from any claims, damages, losses, or liabilities arising from:

• Clinical decisions made on the basis of ProdigEye outputs without appropriate professional review
• Use of the platform outside of its intended scope or validated indications
• Failure to comply with applicable medical device regulations in their jurisdiction
• Any adverse patient outcomes resulting from inappropriate reliance on automated outputs

6. Emergency Situations

ProdigEye is not designed for use in emergency situations requiring immediate medical intervention. If you or a patient are experiencing a medical emergency, including sudden vision loss, severe eye pain, chemical injury to the eye, or penetrating trauma, please contact emergency services immediately.

In Israel: Emergency services 101 (MDA). In the EU: 112. In the US: 911.

7. Contact

For medical and regulatory enquiries regarding this disclaimer: