"We found Silhouette intuitively easy to use, and the most important part is that we know that the data we collect will be accurate and securely stored to prove that our visual assessment of wound dimensional changes have an accurate reference point."
Stuart Collyer Senior Development Scientist, Microarray UK
High Quality Data
"Silhouette gives us confidence in the quality and accuracy of our data."
Dr Philippe Foubert Lead Scientist, Cytori Therapeutics
Easy to Use
"The technology is simplifying the capture of images and measurements. It is extremely convenient and proving valuable in rural hospitals in Africa."
Dr Kingsley Asiedu Medical Officer, World Health Organization, Global Buruli Ulcer Initiative
Ensures Data Confidentiality
"The benefits of using Silhouette have been enormous for us. We have been able to accurately provide detailed measurements across all of our research sites, export the data when we needed it, and the secure database of images and measurements enables all clinicians to see how the wounds are healing without compromising patient confidentiality."
Kimberly Dorsch Director, Global Clinical Affairs, LifeNet Health
Silhouette Operates Across Trial Sites
Silhouette has the following regulatory approvals:
FDA cleared – 510(k) number K070426
Health Canada – Therapeutic Products Directorate
TGA approval (Australia)
WAND registration (New Zealand)
Singapore regulatory clearance
Silhouette also supports compliance with the Code of Federal Regulations (CFR), 21 CFR Part 11 and HIPAA
ARANZ Medical has ISO 13485:2016 Certification
How Silhouette Works
Find out more about our easy to use wound imaging, 3D measurement, and documentation system.