Termes d'utilisation
Le Site est édité par AzMed, société par actions simplifiée immatriculée au RCS sous le numéro Laval B 841 673 601.
The Website is published by AZmed, a simplified joint-stock company registered with the RCS under the number Laval B 841 673 601.
Siège social (adresse postale uniquement) :
6 rue Léonard de Vinci
53000 Laval
Directeur de publication : Julien VIDAL - Directeur général
Courrier électronique : contact@azmed.co
Hébergeur du site : Flux Web
The Website is published by AZmed, a simplified joint-stock company registered with the RCS under the number Laval B 841 673 601.
Siège social (adresse postale uniquement) :
6 rue Léonard de Vinci
53000 Laval
Directeur de publication : Julien VIDAL - Directeur général
Courrier électronique : contact@azmed.co
Hébergeur du site : Flux Web
2. TERMS AND CONDITIONS OF USE
The Website provides information about AZmed’s activities and its artificial intelligence-based solutions designed to assist healthcare professionals in medical imaging analysis (hereinafter referred to as the “Services”). The information provided on the Website is intended for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.
En utilisant le site Web, l'utilisateur reconnaît avoir lu, compris et accepté les présentes conditions d'utilisation. Si l'utilisateur n'accepte pas ces conditions, il doit immédiatement cesser d'utiliser le site Web.
The Website provides information about AZmed’s activities and its artificial intelligence-based solutions designed to assist healthcare professionals in medical imaging analysis (hereinafter referred to as the “Services”). The information provided on the Website is intended for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.
En utilisant le site Web, l'utilisateur reconnaît avoir lu, compris et accepté les présentes conditions d'utilisation. Si l'utilisateur n'accepte pas ces conditions, il doit immédiatement cesser d'utiliser le site Web.
3. NATURE OF INFORMATION PUBLISHED ON THE WEBSITE
The information provided on this Website is for general information purposes only. AZmed makes every effort to ensure the accuracy and timeliness of the information but cannot guarantee that all information is complete or up-to-date. The information on the Website does not constitute medical advice, and AZmed disclaims any liability for actions taken based on the content provided. Healthcare professionals should always rely on their clinical judgment in using our solutions.
4. REGULATORY INFORMATIONS
Indications for use
Rayvolve helps detect:
- Fractures, dislocations and effusion on osteoarticular X-rays of the following organs: hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, leg, knee, femur, clavicle, hip, humerus, pelvis, tibia, ribs and spine.
- abnormalities on chest X-rays such as: consolidation, pleural effusion, pneumothorax, cardiomegaly, acute pulmonary edema, ribs fracture and pulmonary nodules.
- Bone measures' abnormalities (angle/length) on lower limb (including hip, knees, foot) and spine.
- Bones characterisation for bone age abnormalities estimation on hand.
Rayvolve can analyze X-rays of adult and pediatric patients.
The radiographs analyzed are: Computed Radiography (CR), Radio Fluoroscopy (RF) et Digital Radiography (DX).
Undesirable side effects
No adverse side effects related to the use of Rayvolve have been reported.
Warnings
- The users may use Rayvolve only for the intended anatomical regions indicated. Rayvolve is not intended to detect abnormalities from anatomical areas of interest outside the indication for use, the users should review original images for all other suspected pathologies and other anatomical regions and shall rely on their own diagnostic if ever Rayvolve detects abnormalities from anatomical areas outside the indication for use. If Rayvolve encounters an image or an exam outside of the anatomical areas in the instruction for use, it will not be processed by Rayvolve and no Secondary Capture will be generated by Rayvolve. Be careful when you fill in the study description of the exam you perform that the anatomic area of interest is well completed and in the indication for use of the configuration of Rayvolve that you use.
- The same bounding zone can contain several adjacent abnormality: the users shall proceed to a concurrent read with the original X-ray.
- It is possible that a bounding zone hides an adjacent abnormality: the users shall proceed to a concurrent read with the original X-ray.
- Poor image quality can affect Rayvolve's detection of abnormality: the users shall proceed to a concurrent read with the original X-ray.
- The images provided by Rayvolve are AI-aided automated analysis only. It shall not replace a physician’s diagnosis. A disclaimer is displayed on the duplicate and the report generated by Rayvolve.
- Some abnormalities specific to children are not found in adults and may be more difficult to identify. Always use Rayvolve with caution when using in children.
- Rayvolve's features have been optimized and tested to minimize prediction errors, some tolerable residual risks may still exist. Rayvolve may present false negatives for pulmonary and cardiological diseases. The predictions provided by Rayvolve should always be corroborated by a healthcare professional’s judgment to ensure correct interpretation of the results and appropriate patient management. AZmed does not significantly impact vulnerable persons directly.
Contraindication and precautions
- Do not use Rayvolve to detect foreign matters
- Rayvolve works optimally on chest radiographs taken under optimal conditions: when the patient is facing frontally and in full inspiration
Notes
- No residual risks were identified for Rayvolve.
- Rayvolve is not intended to detect abnormalities in other modalities than X-Rays.
- For bone age characterization, if the bone age assessed by Rayvolve is ≥18 years old for a female or ≥19 years old for a male, the bone age will respectfully be indicated by ≥18 or ≥19.
- This product integrates artificial intelligence (AI) technology to support medical image analysis. If a user requests not to use the AI functionality, the product will be deactivated and removed from the site, as its core features depend entirely on AI-based processing.
- Prior to the deployment of the software, AZmed provides training sessions to healthcare professionals to present the product, explain how to interpret its outputs, and address any questions regarding its use in practice.
Performances claimed
Based on standalone performance testing and on the clinical evaluation, we claim that radiologist and emergency physicians:
- improve their performances in detecting and localizing abnormalities on standard radiographs when supported by Rayvolve’s prediction
- reduce their x-rays analysis time
- Reduce intra- and inter-observer variability for reproducibility.
The performance of the system is primarily evaluated using three standard metrics widely recognized in the field of diagnostic detection: sensitivity, specificity, and area under the ROC curve (AUC). The Mean Absolute Error (MAE)is also calculated for measures and bone age. These metrics are considered the international standard for assessing the performance of probabilistic detectors, whether AI-based or not, and directly relate to well-established notions such as false positives and false negatives. They ensure comparability, transparency, and clinical relevance across medical technologies.
Those metrics are configurable, by AZmed, upon the client’s request to better align with the expected results .
The information provided on this Website is for general information purposes only. AZmed makes every effort to ensure the accuracy and timeliness of the information but cannot guarantee that all information is complete or up-to-date. The information on the Website does not constitute medical advice, and AZmed disclaims any liability for actions taken based on the content provided. Healthcare professionals should always rely on their clinical judgment in using our solutions.
4. REGULATORY INFORMATIONS
Indications for use
Rayvolve helps detect:
- Fractures, dislocations and effusion on osteoarticular X-rays of the following organs: hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, leg, knee, femur, clavicle, hip, humerus, pelvis, tibia, ribs and spine.
- abnormalities on chest X-rays such as: consolidation, pleural effusion, pneumothorax, cardiomegaly, acute pulmonary edema, ribs fracture and pulmonary nodules.
- Bone measures' abnormalities (angle/length) on lower limb (including hip, knees, foot) and spine.
- Bones characterisation for bone age abnormalities estimation on hand.
Rayvolve can analyze X-rays of adult and pediatric patients.
The radiographs analyzed are: Computed Radiography (CR), Radio Fluoroscopy (RF) et Digital Radiography (DX).
Undesirable side effects
No adverse side effects related to the use of Rayvolve have been reported.
Warnings
- The users may use Rayvolve only for the intended anatomical regions indicated. Rayvolve is not intended to detect abnormalities from anatomical areas of interest outside the indication for use, the users should review original images for all other suspected pathologies and other anatomical regions and shall rely on their own diagnostic if ever Rayvolve detects abnormalities from anatomical areas outside the indication for use. If Rayvolve encounters an image or an exam outside of the anatomical areas in the instruction for use, it will not be processed by Rayvolve and no Secondary Capture will be generated by Rayvolve. Be careful when you fill in the study description of the exam you perform that the anatomic area of interest is well completed and in the indication for use of the configuration of Rayvolve that you use.
- The same bounding zone can contain several adjacent abnormality: the users shall proceed to a concurrent read with the original X-ray.
- It is possible that a bounding zone hides an adjacent abnormality: the users shall proceed to a concurrent read with the original X-ray.
- Poor image quality can affect Rayvolve's detection of abnormality: the users shall proceed to a concurrent read with the original X-ray.
- The images provided by Rayvolve are AI-aided automated analysis only. It shall not replace a physician’s diagnosis. A disclaimer is displayed on the duplicate and the report generated by Rayvolve.
- Some abnormalities specific to children are not found in adults and may be more difficult to identify. Always use Rayvolve with caution when using in children.
- Rayvolve's features have been optimized and tested to minimize prediction errors, some tolerable residual risks may still exist. Rayvolve may present false negatives for pulmonary and cardiological diseases. The predictions provided by Rayvolve should always be corroborated by a healthcare professional’s judgment to ensure correct interpretation of the results and appropriate patient management. AZmed does not significantly impact vulnerable persons directly.
Contraindication and precautions
- Do not use Rayvolve to detect foreign matters
- Rayvolve works optimally on chest radiographs taken under optimal conditions: when the patient is facing frontally and in full inspiration
Notes
- No residual risks were identified for Rayvolve.
- Rayvolve is not intended to detect abnormalities in other modalities than X-Rays.
- For bone age characterization, if the bone age assessed by Rayvolve is ≥18 years old for a female or ≥19 years old for a male, the bone age will respectfully be indicated by ≥18 or ≥19.
- This product integrates artificial intelligence (AI) technology to support medical image analysis. If a user requests not to use the AI functionality, the product will be deactivated and removed from the site, as its core features depend entirely on AI-based processing.
- Prior to the deployment of the software, AZmed provides training sessions to healthcare professionals to present the product, explain how to interpret its outputs, and address any questions regarding its use in practice.
Performances claimed
Based on standalone performance testing and on the clinical evaluation, we claim that radiologist and emergency physicians:
- improve their performances in detecting and localizing abnormalities on standard radiographs when supported by Rayvolve’s prediction
- reduce their x-rays analysis time
- Reduce intra- and inter-observer variability for reproducibility.
The performance of the system is primarily evaluated using three standard metrics widely recognized in the field of diagnostic detection: sensitivity, specificity, and area under the ROC curve (AUC). The Mean Absolute Error (MAE)is also calculated for measures and bone age. These metrics are considered the international standard for assessing the performance of probabilistic detectors, whether AI-based or not, and directly relate to well-established notions such as false positives and false negatives. They ensure comparability, transparency, and clinical relevance across medical technologies.
Those metrics are configurable, by AZmed, upon the client’s request to better align with the expected results .
5. INTELLECTUAL PROPERTY
All content on this Website, including but not limited to text, graphics, logos, icons, images, videos, software, and trademarks, is the intellectual property of AZmed or its partners and is protected by intellectual property laws. For more details regarding AZmed’s intellectual property rights, including restrictions on use, please refer to our Politique de confidentialité
L'utilisateur se voit accorder le droit non exclusif et non transférable d'utiliser le site Web uniquement pour un usage personnel et non commercial. L'utilisateur accepte de ne pas copier, reproduire, modifier, distribuer, afficher ou exploiter tout contenu du site Web sans l'autorisation écrite préalable d'AzMed.
All content on this Website, including but not limited to text, graphics, logos, icons, images, videos, software, and trademarks, is the intellectual property of AZmed or its partners and is protected by intellectual property laws. For more details regarding AZmed’s intellectual property rights, including restrictions on use, please refer to our Politique de confidentialité
L'utilisateur se voit accorder le droit non exclusif et non transférable d'utiliser le site Web uniquement pour un usage personnel et non commercial. L'utilisateur accepte de ne pas copier, reproduire, modifier, distribuer, afficher ou exploiter tout contenu du site Web sans l'autorisation écrite préalable d'AzMed.
6. USE OF THE WEBSITE
The User agrees to use the Website in a lawful manner and in compliance with these terms and all applicable laws. Users are prohibited from:
- Utiliser le site Web pour transmettre ou publier tout contenu illégal, préjudiciable, diffamatoire ou autrement répréhensible.
-Tenter d'obtenir un accès non autorisé au site Web, aux serveurs ou à tout autre système lié au site Web.
- Se livrer à toute activité susceptible de perturber ou d'interférer avec le bon fonctionnement du site Web.
AzMed se réserve le droit de restreindre l'accès au site Web ou de mettre fin à l'accès de tout utilisateur en cas d'utilisation abusive.
The User agrees to use the Website in a lawful manner and in compliance with these terms and all applicable laws. Users are prohibited from:
- Utiliser le site Web pour transmettre ou publier tout contenu illégal, préjudiciable, diffamatoire ou autrement répréhensible.
-Tenter d'obtenir un accès non autorisé au site Web, aux serveurs ou à tout autre système lié au site Web.
- Se livrer à toute activité susceptible de perturber ou d'interférer avec le bon fonctionnement du site Web.
AzMed se réserve le droit de restreindre l'accès au site Web ou de mettre fin à l'accès de tout utilisateur en cas d'utilisation abusive.
7. DATA PROTECTION AND PRIVACY
AZmed is committed to protecting the privacy of its Users in accordance with applicable data protection laws, including the General Data Protection Regulation (GDPR). For more details on how we collect, process, and protect your personal data, please consult our Privacy Policy
AZmed is committed to protecting the privacy of its Users in accordance with applicable data protection laws, including the General Data Protection Regulation (GDPR). For more details on how we collect, process, and protect your personal data, please consult our Privacy Policy
8. COOKIES
AZmed uses cookies to enhance the User’s experience on the Website. Cookies are small files stored on the User's device that collect certain information about their browsing activity. By continuing to use the Website, the User consents to the use of cookies.
Pour plus d'informations sur l'utilisation des cookies et sur la manière de gérer vos préférences, veuillez consulter notre Politique de confidentialité.
AZmed uses cookies to enhance the User’s experience on the Website. Cookies are small files stored on the User's device that collect certain information about their browsing activity. By continuing to use the Website, the User consents to the use of cookies.
Pour plus d'informations sur l'utilisation des cookies et sur la manière de gérer vos préférences, veuillez consulter notre Politique de confidentialité.
9. THIRD-PARTY LINKS
The Website may contain links to third-party websites. These links are provided for convenience, and AZmed does not endorse or assume any responsibility for the content, products, or services available on those websites. Users are encouraged to review the terms and privacy policies of third-party sites before using them.
The Website may contain links to third-party websites. These links are provided for convenience, and AZmed does not endorse or assume any responsibility for the content, products, or services available on those websites. Users are encouraged to review the terms and privacy policies of third-party sites before using them.
10. LIMITATION OF LIABILITY
While AZmed strives to ensure that the information provided on the Website is accurate and up to date, AZmed makes no warranties, express or implied, regarding the accuracy, completeness, or suitability of the information provided. AZmed shall not be held liable for any direct, indirect, incidental, or consequential damages arising from:
- L'utilisation ou l'impossibilité d'utiliser le site Web ou les services
- Erreurs ou omissions dans les informations présentées
- Accès non autorisé aux données de l'utilisateur ou modification de celles-ci.
AzMed ne garantit pas un accès ininterrompu au site Web et se réserve le droit de modifier, suspendre ou interrompre toute partie du site Web sans préavis.
While AZmed strives to ensure that the information provided on the Website is accurate and up to date, AZmed makes no warranties, express or implied, regarding the accuracy, completeness, or suitability of the information provided. AZmed shall not be held liable for any direct, indirect, incidental, or consequential damages arising from:
- L'utilisation ou l'impossibilité d'utiliser le site Web ou les services
- Erreurs ou omissions dans les informations présentées
- Accès non autorisé aux données de l'utilisateur ou modification de celles-ci.
AzMed ne garantit pas un accès ininterrompu au site Web et se réserve le droit de modifier, suspendre ou interrompre toute partie du site Web sans préavis.
11. DISCLAIMER
AZmed does not warrant that access to or use of the website will be uninterrupted or error-free or that defects in the website will be corrected. This website, including any content or information contained within it or any website-related service, is provided "as is," with all faults, with no representations or warranties of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability, fitness for a particular purpose, quality of information, quiet enjoyment, and title/non-infringement. AZmed does not warrant the accuracy, completeness, or timeliness of the information obtained through the website.
Vous assumez l'entière responsabilité et les risques liés à votre utilisation de ce site Web et de ses services. AzMed ne garantit pas que les fichiers disponibles au téléchargement soient exempts de virus, de vers, de chevaux de Troie ou d'autres programmes destructeurs. Vous êtes responsable de la mise en œuvre de procédures suffisantes pour répondre à vos besoins en matière de sauvegarde et de sécurité des données.
Les garanties relatives aux produits ou services proposés, vendus et distribués par AzMed sont soumises à des conditions générales de garantie distinctes, le cas échéant, fournies par AzMed ou des tiers avec ou en relation avec les services applicables. Vous reconnaissez et comprenez que l'utilisation ou la mauvaise utilisation des services obtenus via notre site Web peut avoir des conséquences indésirables ou inattendues. AzMed n'assume aucune responsabilité pour les conséquences résultant de l'application, de l'utilisation ou de la mauvaise utilisation de tout service contenu sur ou mis à disposition via le site Web, y compris toute blessure ou tout dommage causé à une personne ou à un bien par négligence ou autrement.
AZmed does not warrant that access to or use of the website will be uninterrupted or error-free or that defects in the website will be corrected. This website, including any content or information contained within it or any website-related service, is provided "as is," with all faults, with no representations or warranties of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability, fitness for a particular purpose, quality of information, quiet enjoyment, and title/non-infringement. AZmed does not warrant the accuracy, completeness, or timeliness of the information obtained through the website.
Vous assumez l'entière responsabilité et les risques liés à votre utilisation de ce site Web et de ses services. AzMed ne garantit pas que les fichiers disponibles au téléchargement soient exempts de virus, de vers, de chevaux de Troie ou d'autres programmes destructeurs. Vous êtes responsable de la mise en œuvre de procédures suffisantes pour répondre à vos besoins en matière de sauvegarde et de sécurité des données.
Les garanties relatives aux produits ou services proposés, vendus et distribués par AzMed sont soumises à des conditions générales de garantie distinctes, le cas échéant, fournies par AzMed ou des tiers avec ou en relation avec les services applicables. Vous reconnaissez et comprenez que l'utilisation ou la mauvaise utilisation des services obtenus via notre site Web peut avoir des conséquences indésirables ou inattendues. AzMed n'assume aucune responsabilité pour les conséquences résultant de l'application, de l'utilisation ou de la mauvaise utilisation de tout service contenu sur ou mis à disposition via le site Web, y compris toute blessure ou tout dommage causé à une personne ou à un bien par négligence ou autrement.
12. APPLICABLE LAW AND JURISDICTION
These Terms of Use and any disputes arising out of or in connection with the use of the Website are governed by French law. Any disputes shall be submitted to the exclusive jurisdiction of the courts of Paris, France.
These Terms of Use and any disputes arising out of or in connection with the use of the Website are governed by French law. Any disputes shall be submitted to the exclusive jurisdiction of the courts of Paris, France.
13. CHANGES TO THE TERMS OF USE
AZmed reserves the right to modify these Terms of Use at any time. Any changes will be posted on this page, and the updated terms will be effective immediately upon publication. Users are encouraged to review these Terms of Use regularly to stay informed of any updates.
AZmed reserves the right to modify these Terms of Use at any time. Any changes will be posted on this page, and the updated terms will be effective immediately upon publication. Users are encouraged to review these Terms of Use regularly to stay informed of any updates.
14. CONTACT
For any questions regarding these Terms of Use or the Website, please contact us at: contact@azmed.co
Version approved by AZmed teams: 2025-10-06