BETA
Digital wound imaging, measurement, documentation and analytics for clinical care and research.
eKare provides digital wound imaging and measurement technology through its inSight platform. Founded in 2014 as a spin-off from Children’s National Medical Center, the company combines mobile imaging, wound documentation, workflow tools and analytics for care providers and clinical research organizations.
The company lists its U.S. address in Fairfax, Virginia, alongside a European business in the Netherlands. Patrick Cheng is CEO and co-founder, with Kyle Wu serving as Chief Medical Officer. The product is offered commercially for clinical practice and research workflows.
Company support materials identify inSight as FDA registered under product code FXN, while FDA classification describes the surgical-camera category as 510(k) exempt. This is not a verified 510(k) clearance of every AI feature, diagnostic claim or later software configuration. Product-version and intended-use mapping remain important research boundaries.
Manufacturer support identifies inSight with FDA product code FXN. The reviewed classification is 510(k) exempt; later software configurations and AI claims require separate mapping. Exemption is not FDA approval; intended use, labeling and applicable exemption limitations still govern marketing. [1][2][3][4][8]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [10][11]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Mobile wound imaging, measurement and documentation platform with clinical and research workflows. [7][1][2]
Exemption documentedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial development spans clinical wound-care workflows, research imaging and mobile capture. No blanket FDA authorization is inferred for all AI analytics or newer software functions. [4][3]
Company history describes a 2014 spin-off from Children’s National Medical Center. [7]
Accessed 10/20/2026