“eKare is pleased to announce that it has received ISO 13485 certification and CE mark approval for its inSight™ 3D Wound Assessment system, achieving a critical milestone towards product launch in Europe.”
Wounds. Nov, 2016.
“The 3D-WM was found to be highly reliable for measuring wound areas for a range of wound sizes and types as compared to manual measurement and scaled photography. The depth and therefore volume measurement using the 3D-WM was found to have a lower ICC, but volume ICC alone was moderate. Overall this device offers an affordable mobile option for objective wound measurement in the clinical setting.”
Note: The study involves shallow diabetic foot ulcers with average depth of approx. 1mm and may not be appropriate to evaluate depth measurement. See “Discussion” on page 5.