FAQ & Support

Pixacare combines all key tools needed for photographic and clinical wound monitoring in one interface:

• Secure medical photo and video library
• Wound healing documentation with measurements and assessments
• ePRO-based remote monitoring
• eCRF data collection for research and RWE studies
• Secure messaging for care coordination

Pixacare helps clinicians save time and improve coordination by automating documentation. With Pixacare, users can:

• Capture and organize photos and videos automatically
• Measure and analyze wounds using AI (CE Class IIa certification in progress)
• Perform manual measurements directly on images
• Complete standardized clinical questionnaires
• Generate wound healing reports and visual progress charts
• Collaborate securely with other care team members
• Export data to EHRs or tele-expertise platforms

Yes. Pixacare includes built-in collaboration tools:

• Secure messaging for private or group discussions between healthcare professionals
• Collaborative workspaces that allow teams to access and update patient data together, with full traceability and role-based access

Pixacare supports industry-standard formats and integrations, including:

• PDF reports
• CSV and XLSX exports
• Medical DICOM and JPEG images
• Secure REST APIs, HL7, SFTP, and FHIR
• Native interoperability with major EHRs and tele-expertise platforms

All data exchanges are fully encrypted and compliant with GDPR, HDS, and ISO 27001 standards.

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Pixacare uses artificial intelligence to automatically measure wound surface area and tissue composition (granulation tissue, fibrin/slough, necrosis) from a calibrated photo taken with a calibration sticker.

This standardized approach ensures objective and reproducible measurements, regardless of the user or the device used.

Pixacare enables care teams to monitor patients remotely through the application. Clinical data is received in real time, allowing hospital teams to track healing progress and intervene when needed.

Two remote monitoring workflows are available:

• ePRO remote monitoring (patient-reported outcomes)
• Independent patients receive a secure SMS link to submit photos and questionnaires.
• Nurse-assisted remote monitoring
• Nurses use Pixacare directly to document wounds and securely transmit data to the hospital team via the built-in messaging system.

Yes. Pixacare allows teams to create work groups, exchange secure messages, and share clinical cases across departments or healthcare facilities.

Yes. Pixacare can be used in offline mode. Photos and data captured offline are automatically synchronized as soon as an internet connection is restored (Wi-Fi or 4G/5G).

Yes. Pixacare’s eCRF module supports the collection, structuring, and export of clinical data for clinical trials and Real-World Evidence (RWE) studies.

It enables multicenter follow-up, full traceability, and secure, auditable data management.

Pixacare’s AI automatically measures and analyzes wounds from calibrated photos.

It standardizes clinical observations, improves measurement reliability, and helps clinicians objectively track healing over time.

To enable automatic measurement, a calibration sticker is placed on healthy skin near the wound before taking a photo.

Pixacare provides real-time visual feedback:

• Green indicators confirm proper calibration
• Red indicators signal that the photo should be retaken

Once validated, the AI:

• Automatically outlines the wound
• Calculates surface area in cm²
• Analyzes tissue composition (granulation tissue, fibrin/slough, necrosis) and estimates their relative proportions

Calibration stickers are included with paid plans (Pro, Facility, or Research).

When supplies run low, users can contact customer support to request more. Restocking is typically shipped within 48 business hours.

For Research plans, stickers may be treated as a consumable and supplied separately, depending on contract terms.

No. Pixacare’s AI provides objective measurements and visual analysis only.

Clinical interpretation and medical decisions always remain the responsibility of the healthcare professional.

By standardizing measurements, Pixacare’s AI establishes a consistent measurement reference across sites and studies.

This supports reliable, traceable, and auditable data, making it well suited for RWE projects and multicenter clinical trials.

Yes. The AI modules WoundTrack (semi-automated) and WoundSize (fully automated) were validated in the PIXAIRE1 study, conducted at Haguenau Hospital (Vascular Surgery Department).

Results (pending publication in the International Wound Journal) show a strong correlation between Pixacare measurements and digitized planimetry, the reference standard.

Pixacare’s algorithms are trained on thousands of expert-annotated clinical images and validated through clinical studies.

Development follows an ISO 13485–certified quality management system, ensuring rigor, traceability, and safety.

Yes. Pixacare’s calibration sticker is based on a patented technology that automatically adjusts for color, angle, and distance.

This ensures reliable and reproducible measurements, regardless of smartphone model or lighting conditions.

The AI module is currently undergoing CE Class IIa certification under the EU Medical Device Regulation (MDR).

Once approved, it will be registered as a Software as a Medical Device (SaMD) under the name WoundTrack II.

Several peer-reviewed and ongoing studies support Pixacare’s clinical value:

Kuster et al. (2021) — Medical photography efficiency and data security

• Image acquisition time reduced by 3.8× (from 259 seconds to 69 seconds)

Chevalier et al. (2024) — Post-operative monitoring of digital flaps

• Strong agreement between in-person and remote assessment (Kappa = 0.64)
• High user satisfaction (4.63 / 5)

Maxant et al. (International Wound Journal, 2025) — Medico-economic impact of remote monitoring for chronic wounds

• 35-day reduction in average healing time
• 55% fewer in-person consultations
• €1,666 saved per patient

Maxant et al. (submitted, publication expected 2026) — Automated wound surface measurement

• Comparison of WoundTrack (semi-automated) and WoundSize (automated) vs. digitized planimetry
• High inter-expert reliability (ICC > 0.9)
• No significant difference vs. reference planimetry, including for small wounds (< 8 cm²)
• WoundSize shown to be fast and reliable within an “AI suggestion → clinician validation” workflow

All Pixacare-related scientific publications are available on the dedicated page: pixacare.com/etudes-et-publications

They highlight Pixacare’s clinical reliability, medico-economic value, and safe use for medical photography, remote monitoring, and AI-based wound measurement.

Yes. Pixacare is currently involved in several ongoing studies, including:

• Prof. Guerreschi (Lille University Hospital): medico-economic impact of chronic wound remote monitoring
• Dr. Dardari (South Francilien Hospital): feasibility study for diabetic foot ulcer remote monitoring
• Dr. Maxant (Haguenau Hospital): continuation of the PIXAIRE program, focusing on improving algorithm accuracy using an “AI suggestion → clinician validation” approach

Pixacare complies with:

• GDPR (data protection and privacy)
• ISO 13485 (quality management for medical devices)
• CE marking under EU MDR (2017/745)
• Hosting by providers certified ISO 27001 and HDS
• HIPAA compliance for international deployments

All data is end-to-end encrypted and protected by strict access control policies.

Pixacare exclusively uses hosting providers certified for health data security:

• France & Belgium: OVH or Microsoft Azure France
• Europe: OVH or sovereign Microsoft Azure, depending on local regulations
• United States: Microsoft Azure US (HIPAA compliant)
• Other regions: local Microsoft Azure hosting to meet data residency and sovereignty requirements

No cross-border data transfers occur without appropriate regulatory safeguards.

Yes. Pixacare is HIPAA compliant and can provide a Business Associate Agreement (BAA) upon request.

Access is strictly limited to authorized users based on role-based access control (RBAC) defined by the healthcare organization.

Pixacare supports strong authentication options, including:

• Single Sign-On (SSO): SAML 2.0, OAuth, OpenID Connect
• Two-factor authentication (2FA)

No. Photos are encrypted immediately and transmitted directly to secure servers.

No patient image is stored in the device’s photo gallery.

• Data is retained for the duration of the contract
• At contract end, data is returned to the customer and securely deleted
• Patients and users can exercise their data rights via Pixacare’s Data Protection Officer (DPO)

Pixacare follows a structured incident response process:

1. Identify and isolate the affected system
2. Notify the DPO and perform an impact assessment
3. Inform customers in accordance with GDPR requirements
4. Implement corrective actions and document the incident

Yes. Pixacare complies with the EU Medical Device Regulation (MDR 2017/745).

Its AI modules are currently undergoing CE Class IIa certification.

Pixacare is deployed with end-to-end support from the Pixacare team. Each project is tailored to the organization’s size, workflows, and technical environment.

Deployment typically includes:

• Initial configuration and user space setup
• Training for clinical and administrative teams
• Integration with existing hospital systems
• Post-deployment monitoring and ongoing support

Yes. Pixacare is designed for seamless interoperability with most hospital information systems and EHRs.

Supported integration methods include:

• Secure REST APIs
• HL7 messaging (ADT, ORU, MDM)
• SFTP for automated data exchange
• Patient Administration System (PAS / GAM – Pastel) connectors for patient identity management

Pixacare is compatible with leading EHRs such as Orbis, Sillage, Crossway, DxCare, Easily, and others.

Yes. Pixacare supports HL7 FHIR R4, enabling modern, standardized exchange of:

• Patient demographics
• Clinical observations
• Medical images

This ensures native interoperability with modern EHRs and digital health platforms.

Pixacare runs on standard devices with no complex installation required:

• Smartphone or tablet (iOS or Android)
• Secure web browser (Chrome, Safari, Edge, Firefox)
• Internet connection (Wi-Fi, 4G/5G, or hospital network)

Access is provided via a secure link, making deployment fast and simple.

On average, full deployment takes 2 to 4 weeks, depending on:

• The size of the organization
• The number of departments involved
• The level of integration required (EHR, API, eCRF, etc.)

Yes. Training is included with every deployment and can be adapted to your needs:

• Remote training sessions for small teams
• On-site training for large-scale deployments

Additional resources such as user guides and interactive tutorials are available through the Pixacare Help Center.

For optimal performance, Pixacare is recommended on recent devices:

• iOS 14 or later
• Android 10 or later
• Camera resolution ≥ 12 MP with active autofocus
• At least 1 GB of free storage

Recommended devices include iPhone 11 or later and Samsung Galaxy S20 or later.

Not yet. Remote monitoring of chronic wounds is not currently reimbursed under standard care pathways.

However, several medico-economic studies are underway to support future reimbursement frameworks, including initiatives similar to PECAN (chronic wound care reimbursement pathways).

Yes. Data documented in Pixacare can be used for tele-expertise and care coordination, thanks to native integrations with platforms such as Rofim and Omnidoc.

These integrations ensure medical traceability while supporting billing for coordination activities.

Yes. Several public funding mechanisms can support Pixacare deployment, including:

• Regional or hospital group funding, often through Regional Health Agencies, for remote monitoring and hospital–community coordination
• National innovation programs, such as Bpifrance or France 2030, supporting digital transformation in healthcare

Pixacare assists organizations in building funding applications and demonstrating the medico-economic value of their projects.

To receive support for a funded remote monitoring or digital health innovation project, simply contact Pixacare’s eHealth project team via the contact form.

The team will guide you through:

• Available funding programs
• Eligibility criteria
• Operational rollout within your organization

Yes. Pixacare is available worldwide 🌍

• For individual clinicians or private practices, Pixacare can be used immediately with a Pro license.
• For hospitals, clinics, or healthcare networks, deployment is tailored to local requirements and typically starts with a custom quote.

👉 Contact the sales department for international support.

Pixacare is available in English, French, and Spanish, supporting healthcare organizations across:

• Europe
• North and South America
• Multilingual regions and international research projects

Additional languages can be considered depending on deployment needs.

Yes. Pixacare is designed to meet international regulatory requirements, including:

• CE-marked medical device (EU MDR 2017/745)
• ISO 13485–certified quality management system
• HIPAA compliance for deployments in the United States

Pixacare’s architecture allows compliance with local healthcare and data protection regulations in each country of deployment.

Pixacare supports regional and local data hosting to ensure compliance with data residency and sovereignty requirements:

• France & Europe: OVH or Microsoft Azure (HDS and ISO 27001 certified)
• United States: Microsoft Azure US (HIPAA compliant)
• Other regions: local Microsoft Azure hosting, aligned with local regulations

No cross-border data transfers occur without appropriate legal and regulatory safeguards.

Pixacare offers flexible pricing, tailored to different usage profiles. Pricing is provided upon request, based on deployment scope and needs.

Available plans include:

• Free version: limited storage, no AI features
• Pro plan: individual use with access to AI modules
• Organization plan: multi-user deployment with EHR integration and dedicated onboarding
• Research plan: full eCRF module for clinical trials and RWE studies
• Guest access: free for community nurses and patients involved in hospital-led remote monitoring programs

👉 To receive a personalized quote, contact the Pixacare sales team.

All Pixacare plans include:

• Secure, HDS-certified hosting for patient data
• Technical support by email or phone
• Automatic updates for mobile and web applications

You can contact Pixacare support directly from the application:

Menu → Help → Contact us,

or via the online form

The support team answers under 24 to 14 business hours on average.

Yes. Pixacare provides a comprehensive Help Center with:

• Step-by-step user guides
• Video tutorials
• Technical FAQs
• Best practices for clinical use

These resources are available anytime and are regularly updated as the product evolves.