An overview and survey of US Food and Drug Administration-registered wound imaging devices capable of determining percentage area reduction and/or percentage volume reduction

Area of Science:

• Wound care technology
• Medical device evaluation
• Data collection in research

Background:

• High-quality research relies on validated data collection tools.
• Comprehensive reporting guidelines were developed for essential wound care tools.
• The Wound Care Collaborative Community (WCCC) aims to improve wound assessment.

Purpose of the Study:

• Identify wound imaging devices measuring percentage area reduction (PAR) and/or percentage volume reduction (PVR).
• Assess features of wound imaging devices used in clinical practice.
• Evaluate the reliability of wound imaging devices for tracking wound healing.

Main Methods:

• Collected data from public databases and manufacturer surveys (Q4 2023, Q2 2024).
• Included medical devices with FDA FXN classification capable of length and width measurements.
• Focused on devices currently marketed by FDA-listed establishments.

Main Results:

• 14 wound imaging devices from 13 FDA-registered establishments met inclusion criteria.
• 10 manufacturers participated in the WCCC survey.
• Seven tables summarize device features and measurement capabilities.

Conclusions:

• Most wound imaging devices measure PAR, often using perimeter and various area calculations.
• Device measurements show less variation than traditional ruler methods.
• Advanced features like 3D modeling and skew correction enhance device accuracy and reliability for tracking wound healing.