Modulated Imaging Receives FDA Clearance for New Imaging System

News Brief
August 15, 2018 By Jackie Connor

Startup company Modulated Imaging has received FDA 510(k) clearance to market its new noninvasive medical device, the Clarifi Imaging System. The company leverages medical photonics and informatics, or light as a medium to gather information to help clinicians assess a patient’s tissue health. With the FDA clearance, Modulated Imaging will promote their technology to clinicians across the nation.

“We’re proud to be able to provide meaningful information that advances a patient’s health and wellness,” said David Cuccia, Ph.D., CEO and CTO, Modulated Imaging. “Clarifi can lead to significant preventive care actions as well as over $6 billion per year in savings to the U.S. healthcare system.”

Cuccia and Amaan Mazhar, vice president of R&D, Modulated Imaging, developed the proprietary technology and began their journey towards commercialization at the University of California, Irvine’s Beckman Laser Institute. The company’s management team has worked closely with UCI Applied Innovation as mentors and event guest speakers at the Cove @ UCI. In 2016 the Cove Fund, LLC, made one of its first investments when it participated in Modulated Imaging’s seed funding round.

“UCI Applied Innovation has played a critical role in our success, from straightforward IP licensing and early access to capital via the Cove Fund, to productive networking events and use of their facilities,” said Cuccia. “We’re grateful to the whole team at Applied Innovation for their continued support of Modulated Imaging.”

Modulated Imaging is the first company to commercialize a diagnostic medical device that uses spatial frequency domain imaging, a method that assesses the condition of biological tissues.

“Clarifi is a powerful example of how cutting edge optical imaging and computational technologies can be combined to create new, accessible tools for precision medicine,” said Bruce Tromberg, Ph.D., director of Beckman Laser Institute and Medical Clinic at UC Irvine.

Clarifi provides diagnostic information that can be used to identify at-risk patients as well as manage and/or treat different types of challenging medical conditions, such as peripheral vascular disease, diabetic foot ulcers, burns, skin flaps, and chronic wounds.

For more information about Modulated Imaging, click here.