Gleamer Copilot® is a marketing term encompassing all Gleamer's solutions. Regulatory information about each individual solution's regulatory clearance status is available below.

BoneView (including BoneAge and BoneMetrics functionalities) is a Class IIa medical devices manufactured by GLEAMER and whose conformity assessment has been carried out by the notified body BSI CE 2797 relative to the 2017/745 regulation. It is software using deep learning techniques intended to provide preliminary data for helping clinicians’ diagnosis of X-ray radiographs.

ChestView is a Class IIa medical devices manufactured by GLEAMER and whose conformity assessment has been carried out by the notified body BSI CE 2797 relative to the 2017/745 regulation. It is software using deep learning techniques intended to provide preliminary data for helping clinicians’ diagnosis of X-ray radiographs.

BreastView is a Class IIa medical device manufactured by GLEAMER and whose conformity assessment has been carried out by the notified body BSI CE 2797 relative to the 2017/745 regulation. It is a software using deep learning techniques intended to be used as a concurrent reading aid for clinicians to help identify findings on mammograms.

BoneCT and LungCT are Class IIa medical devices manufactured by GLEAMER and whose conformity assessment have been carried out by the notified body BSI CE 2797 relative to the 2017/745 regulation. They are software using deep learning techniques intended to be used as a concurrent reading aid for clinicians to help identify findings on CT scans.

Instructions for use are available here.

Pixyl.Neuro is a Class IIa medical device manufactured by PIXYL and whose conformity assessment has been carried out by the notified body TUV RHEINLAND CE 0197 relative to the 2017/745 regulation. It is a software intended for the automatic labelling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MRI images. Volumetric measurements may be compared to reference percentile data.

LumbarMR is not yet available for commercial use and is currently in the process of obtaining its first CE marking.

BoneView US is a class II medical device that has been cleared by the FDA under K222176. BoneView US is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs. For more information on precise indications for use, warnings, and limitations of the software, refer to the 510(k) summary available on FDA’s website. Please read the instructions for use carefully.

ChestView US is a class II medical device that has been cleared by the FDA under K241620. ChestView US is a radiological Computer-Assisted Detection (CADe) software device that analyzes frontal and lateral chest radiographs of patients presenting with symptoms (e.g. dyspnea, cough, pain) or suspected for findings related to regions of interest (ROIs) in the lungs, airways, mediastinum/hila and pleural space. The device uses machine learning techniques to identify and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Nodule, Pleural space abnormality, Mediastinum/Hila abnormality, and Consolidation. For more information on precise indications for use, warnings, and limitations of the software, refer to the 510(k) summary available on FDA’s website. Please read the instructions for use carefully.

BoneMetrics US is a class II medical device that has been cleared by the FDA under K241593. BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. For more information on precise indications for use, warnings, and limitations of the software, refer to the 510(k) summary available on FDA’s website. Please read the instructions for use carefully.

Instructions for use are available here.

No other Gleamer product is currently available in the US.

BoneView is a class II medical device that has been cleared by the Health Canada under License 112750. BoneView is a software using deep learning techniques intended to provide preliminary data for helping clinicians’ diagnosis of X-ray radiographs. For more information on precise indications for use, warnings, and limitations of the software, refer to the instructions for use and read them carefully.

Instructions for use are available here.

No other Gleamer product is currently available in Canada.

For other geographies, product availability is contingent on obtaining relevant local regulatory clearances. Please contact your GLEAMER representative to enquire about current availability in your region.

Instructions for use are available here.

Our company is certified with ISO 13485:2016

GLEAMER is committed to protecting the personal information and privacy of website visitors and anyone using its services in general (including patients of GLEAMER Users whose personal data may be processed through GLEAMER Solutions).

The purpose of this Personal Data Protection and Cookies Policy (Privacy Policy) is to inform you about:

• The types of personal data we collect about you
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• How your personal data is processed by GLEAMER and its potential partners and subcontractors
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• The terms and conditions of use of your personal data and your rights in this regard, in compliance with applicable European and French legislation (and, to the extent applicable, any applicable national legislation related to privacy or data protection in the country where you are located).

All operations involving your personal data are carried out in compliance with the regulations in force, notably Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (hereinafter referred to as the “GDPR”), and any applicable national legislation related to data protection.

If you are located outside of France or the European Union, please refer to Article 10 (Country-specific Information) at the end of this Privacy Policy for important additional information.

• The “website” refers to the infrastructure developed by GLEAMER in Internet-compatible computer formats, comprising data of various types, including texts, sounds, still or moving images, videos, databases, intended to be viewed and accessible at the address: www.gleamer.ai;
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• "GLEAMER Solutions" means GLEAMER's artificial intelligence solutions for reading and analyzing medical images (including those described above);
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• "GLEAMER Users" means healthcare professionals and health service providers that use GLEAMER Solutions to assist them in providing healthcare to patients;
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• “Internet” refers to various networks of servers located in different places around the world, interconnected through communication networks and communicating using a specific protocol known as TCP/IP;
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• “File” refers to any structured and stable set of personal data accessible based on specific criteria;
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• “Personal data”, “special categories of data”, “processing / processing” have the same meaning as in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data;
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• The “Data Controller” is the entity that collects and processes personal information (personal data) and determines the purposes and means for processing that personal data;
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• The “Processor” : any person who agrees to process personal data on behalf of the Data Controller or access personal data in the course of their duties, in accordance with the Data Controller’s instructions;
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• The “Recipients” refer to any person authorized to receive communication of data other than the Data Controller, the Processor, and individuals who, due to their roles, are responsible for processing the data;
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• The “Authorized Third Parties”: refer to authorities legally empowered, within the scope of a specific mission or the exercise of a right to request, to ask the Data Controller to provide them with personal data;
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• “Data Subject”: refers to an individual to whom Personal Data pertains;
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• A “processing of personal data” means any operation or set of operations which is performed upon personal data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

This Personal Data Protection and Cookies Policy (Privacy Policy), hereinafter the “Policy”, aims to inform Data Subjects about how their Personal Data is collected and processed by GLEAMER.

Personal Data is collected by GLEAMER, whose registered office is located at 14 avenue du Général de Gaulle 94160 Saint Mandé, France, registered with the RCS under the number 834 105 470, represented by Christian ALLOUCHE, in his capacity as President.

GLEAMER is committed to protecting the privacy of its users in compliance with current regulations, particularly the amended law “Informatique et Libertés” (Data Protection Act) No. 78-17 of January 6, 1978, and the European Regulation 2016/679 on data protection.
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1. Personal Data collected, purposes, and legal bases.

As part of the operation of the website www.gleamer.ai, GLEAMER may collect Personal Data about you. These data are processed in accordance with the purposes specified during collection, namely:

Categories of collected data: Contact (identity and contact details)

Purposes: Management of information requests and contact requests

Legal basis: Legitimate interest

Retention period: Duration necessary for processing requests

Categories of collected data: Personal data from demo requests (name, first name, email)

Purposes: Management of solution demonstration requests and contact requests, management of commercial prospecting

Legal basis: Legitimate interest and consent

Retention period: 3 years after the last contact initiated by you or as part of your objection

Categories of collected data: Cookies (tracking cookies) and other trackers

Purposes: Compile statistics on site traffic based on analyses

Legal basis: Consent

Retention period: 13 months

The data identified by an asterisk within the forms is mandatory. Failure to provide them will make it impossible for the data subject to access and use the Services or fulfill a request related to a form.

Other data is optional, and their non-provision will not affect the delivery of promised services or responses to inquiries, although it may limit their relevance.

Furthermore, GLEAMER may collect Personal Data for other purposes, subject to obtaining the prior consent of the individuals concerned (where required by law). In particular, GLEAMER may collect the following data :

• Identity: name, first name, email address;
• Personal life data: client’s company;
• Contact data: messages sent on the site via contact forms, correspondence that might be sent to us.
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GLEAMER Users also provide GLEAMER with access to certain Personal Data for the purpose of using the GLEAMER Solutions. This may include Personal Data of the GLEAMER Users themselves, and of patients cared for by the GLEAMER Users, such as:

• Patient administrative data;
• Patient health data, including but not limited to medical imaging examinations and reports;
• Administrative data of the GLEAMER User;
• Pseudonymized patient health data, including but not limited to medical imaging examinations and reports;
• Pseudonymized patient administrative data necessary for GLEAMER Users to access and use the GLEAMER Solutions.
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Where GLEAMER receives Personal Data in this context, the GLEAMER User is the Data Controller and GLEAMER is the Processor. GLEAMER processes the Personal Data for the following purposes:

• Installation, support, updating and maintenance of the GLEAMER Solutions, including anonymization;
• Hosting; and
• Data destruction.

The nature of the processing carried out on the Personal Data includes collection, access, recording, use, anonymization where applicable, organization, structuring, hosting, destruction.

Generally, this processing is conducted for the purpose of providing GLEAMER Users with the functionality of the GLEAMER Solutions (including artificial intelligence-enabled reading and analysis of medical images). GLEAMER Users may use the results of this processing to assist them with providing healthcare to the relevant patient.

GLEAMER Solutions implement measures to protect patient privacy, including the segregation of data and the deployment of pseudonymisation techniques to limit the amount of personal information GLEAMER receives in order to process and analyse the medical images for GLEAMER Users.

Where authorised by GLEAMER Users, GLEAMER may also apply an anonymization procedure to pseudonymized patient data to produce anonymized information within the meaning of the G29 opinion on anonymization techniques. The resulting anonymized information is not Personal Data, and GLEAMER may use this anonymised information for GLEAMER's own business purposes (including for the purpose of training or developing GLEAMER Solutions or any other solutions, algorithms or software).

GLEAMER engages subprocessors to provide various technology services that are used to operate the GLEAMER Solutions, such as data hosting services and database administration services.

If you are a patient of a GLEAMER User, GLEAMER may receive and process your Personal Data as part of the GLEAMER Solutions as described above. GLEAMER takes reasonable steps to ensure that GLEAMER Users notify (and, if required by applicable laws, obtain consent from) their patients where GLEAMER Solutions may be used to process the patient's Personal Data.

b) Recipients of the Collected Data

The database created during the registration for the Services is strictly confidential. GLEAMER undertakes to take all necessary precautions, organizational and technical measures appropriate to preserve the security, integrity, and confidentiality of the Data, and in particular, to prevent them from being distorted, damaged, or accessed by unauthorized third parties.

c) Data transferred to authorities and/or public bodies

In accordance with current regulations, data may be transmitted to competent authorities upon request, particularly to public bodies, exclusively to meet legal obligations, legal auxiliaries, ministerial officers, and organizations responsible for debt collection.

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In accordance with Regulation (EU) 2016/679 regarding the protection of Personal Data, you have the right to request the controller to access your personal data, as well as the rectification or erasure of such data, and the limitation of the processing of your Personal Data.

You also have the right to object to the processing of your Personal Data for legitimate reasons, as well as the right to object to the use of your data for commercial prospecting purposes.

Finally, you have the right to establish general and specific guidelines defining how you intend your rights to be exercised after your death.

If you believe, after contacting us, that your rights regarding your personal data are not being respected, you can file a complaint with the CNIL or the Supervisory Authority in your place of residence.

To exercise these rights or for any questions regarding the processing of your data in this system, you can contact our Data Protection Officer (DPO), providing proof of your identity by referencing your customer number or any element that can identify you; otherwise, please attach a copy of your identity document.

To exercise your rights, you can contact GLEAMER’s Data Protection Officer (DPO) :

• by a simple request via email to the following address: DPO@gleamer.ai
• by postal mail: 5 avenue du Général de Gaulle - 94160 Saint Mandé, France

GLEAMER undertakes that the collected data will be kept in a form allowing the identification of the Data Subjects for a period not exceeding the time necessary for the purposes for which they are collected and processed.

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The personal data collected on the website is exclusively reserved for GLEAMER. GLEAMER is the sole recipient of this data. No transfer is made outside the European Union. However, GLEAMER reserves the right to transmit your personal data to fulfill its legal obligations, especially if required by a court order.

GLEAMER enables you to receive commercial offers and information via email.
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Individuals concerned may, at any time, object to targeted advertising on the website and inform GLEAMER that they no longer wish to receive commercial offers or information. You can opt out of receiving these messages at any time by clicking the link at the end of each email message.

GLEAMER implements all necessary technical and organizational measures to ensure the security and confidentiality of the personal data collected and processed. This includes preventing data from being distorted, damaged, or disclosed to unauthorized third parties, ensuring a level of security appropriate to the risks associated with the processing and the nature of the data to be protected, considering the technological state of the art and the cost of implementation.

GLEAMER has established a policy for the protection of personal data and informs all individuals acting under its authority who access this information about its confidential nature.

Furthermore, GLEAMER ensures that its technical service providers who may have access to personal data adhere to the same confidentiality standards.

However, it is the responsibility of each user to ensure the security of personal data transmissions over the internet. GLEAMER cannot be held responsible for personal data transmissions over the internet.

This policy comes into effect on November 25^th 2025. To check for updates to our Policy, it is advisable to regularly visit this page.

For questions:

The Data Protection Officer (DPO) of GLEAMER is at your disposal for any further information regarding the use of your data :

By email: DPO@gleamer.ai‍

By postal mail: 5 avenue du Général de Gaulle - 94160 Saint Mandé, France

For Australian Data Subjects:
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You may have rights under Australian privacy laws including the Privacy Act 1988 (Cth) (the Australian Privacy Act).

References to "Personal Data" in this Policy include "personal information" as defined in the Australian Privacy Act.

GLEAMER is a multinational business, headquartered in France. If GLEAMER collects and processes your Personal Data (as described in this Policy), your personal information may be transferred / disclosed to, hosted in, and processed in, countries other than Australia (including France and other European Union countries). These countries may have data protection laws that are different to the Australian Privacy Act (and, in some cases, may not be as protective).

Nothing in this Policy purports to exclude, modify, or restrict your rights under Australian laws (including the Australian Privacy Act).

The Australian Privacy Act gives individuals various rights, including the right to:

• request access to, or correction of, your personal information; and
• the right to complain about how your personal information has been handled.

If you would like to make an access or correction request, or lodge a privacy complaint, please contact our Data Protection Officer using the details in Article 9 above.

We will handle all such requests, complaints, and queries in accordance with any applicable requirements under Australian privacy laws. Where applicable, we may rely on exemptions under those laws (including, but not limited to, exemptions relating to related bodies, corporate and employee records).

Our usual process for handling complaints is to appoint a staff member to review your complaint, gather relevant facts and documents, discuss with relevant parties, and then decide what steps (if any) are appropriate for us to take in response to your complaint. In seeking to resolve your complaint we will first consider whether there are any simple or immediate steps which can be taken to address your concern. If your complaint requires more detailed consideration or investigation we will generally contact you to provide an initial acknowledgement that we have received your complaint and are investigating it, and we may ask you to provide further information about your complaint and the outcome you are seeking. Once we have completed our consideration and investigation, we will then contact you to inform you of our decision.