Modulim Receives 3-year Renewal of ISO-13485 Certification

Irvine, CA—January 7, 2024—

Modulim received a three-year renewal of their ISO:13485 certification after a comprehensive review of the company’s quality system, which covers capabilities such as design, manufacturing, and customer management. “Receiving a 3-year renewal highlights the robustness of Modulim’s quality system, and the ability of the team to maintain and scale our processes,” shared Kyle Van Volkinburg, VP of Engineering. “This milestone puts us in a great position to continue building high-quality products—those in production, and those coming on our roadmap”, added David Cuccia, CTO.

Modulim is currently developing a new handheld imaging camera, funded by a contract from the US Army collaborator Medical Technology Enterprise Consortium (MTEC), to address the military needs for a point-of-care digital burn assessment tool.

About Modulim

Modulim delivers transformative imaging and data solutions that empower clinicians to better diagnose, treat, and manage lower limb complications. Clarifi®, powered by Spatial Frequency Domain Imaging (SFDI) technology, quantifies and maps tissue health at the point-of-care through non-contact rapid microvascular assessment. Modulim Cloud™ promotes timely, proactive data-driven decisions to better manage patient care by digitally connecting clinicians and healthcare systems. Modulim is based in Irvine, CA, with a team dedicated to delivering powerful healthcare solutions that revolutionize the standard of care for patients with diabetes, kidney disease, and peripheral vascular disease.

Clarifi is a registered trademark of Modulated Imaging (dba Modulim).


Blake Byrne