Wound Assessment Device

Advanced imaging technology for precise wound measurement, tracking, and bacterial load evaluation

System Characteristics

Sensors and Measurement

Thermal Cam - 640x480 px - ±1°C
Bioluminescence camera: 3840x2160 px
Measurement camera: 3840x2160 px
Wound measurement area: ±8%
Presicion distance sensor: ±1mm
Internal safety sensors and fuel-gauge

Processing and Analysis

Convolutional Neural Networks (CNNs) for wound classification
Wound trend analysis
Application developed in C, Python, Java and Javascript
Hardware powered by STM32 and OEM cameras

Interface and Safety

Portable device: only 650g
Battery powered
Intuitive interface with user profiles
User centered design
Initial GDPR compliance implementation plan
End-to-end data encryption

Certifications and Regulatory Compliance

IEC 60601-1

Basic Safety and Essential Performance

IEC 60601-1-2

Electromagnetic Compatibility

ISO 14971

Application of Risk Management to Medical Devices

IEC 62304

Medical device software - Software life cycle processes

IEC 62471

Photobiological safety of lamps and lamp systems

Project Description

This portable medical device enhances physicians' diagnostic capabilities by extracting key wound parameters invisible to the naked eye. It achieves this through a combination of specialized cameras, light sources, sensors, and AI.

Integrated with an online platform, it has the potential to revolutionize the wound-assessment market, benefiting countless patients.

Developing this device introduced new challenges, including design for manufacturability (DfM) for high production volumes, image processing and refinement, and the development of AI features tailored to medical applications.