Modulated Imaging receives FDA clearance for Clarifi system

08 Aug 2018

Imaging platform uses structured light to assess tissue oxygenation

An imaging platform based on structured light that can measure oxygenation and hemoglobin levels in superficial tissue has now received FDA 510(k) clearance.

The Clarifi device, developed by California-based Modulated Imaging, employs spatial frequency domain imaging (SFDI), a near-infrared imaging approach providing quantitative determination of the optical properties and in vivo concentrations of chromophores over a wide field-of-view.

Clarifi is said by the company to represent the first commercialized diagnostic medical device employing the technology. FDA approval comes nearly a year after the company raised $2.9 million in a series A round of venture funding in support of its development program.

"We’re proud to be able to provide meaningful information that advances patients’ health and wellness," said David Cuccia, CEO and CTO of Modulated Imaging. "FDA clearance is a major milestone for our company. Clarifi can lead to significant preventive care actions as well as over $6 billion per year in savings to the US healthcare system."

Clarifi is a non-contact noninvasive system that measures tissue oxygen saturation (StO₂), oxyhemoglobin (HbO₂), and deoxyhemoglobin (HbR) parameters. According to the company, it is the first noninvasive diagnostic technology to quantitatively display total hemoglobin levels in superficial layers (up to 1 mm deep) and subsurface layers (1.5 to 3 mm) of tissue.

"Other groups are experimenting with SFDI, including applying it via endoscopy in ovarian cancer patients, but as far as we know, we are the first to truly commercialize the technology for medical diagnostics," Gary Marston of Modulated Imaging commented to Optics.org. "Clarifi was preceded by our Ox-Imager CS device, which was intended to prove the concept and the technology. But the engineering and acquisition model for Clarifi are designed for easy integration and widespread adoption in a wide variety of care settings, especially in managed care."

Marston noted that Clarifi had been optimized for use in a such outpatient settings, with corresponding cost-effectiveness and ease of use, along with reduced sensitivity to environmental conditions. "In addition, we now display hemoglobin measurements for papillary and reticular dermis, which provides clinicians greater insight in microvascular circulation and perfusion," he said.

New tools for precision medicine

SFDI, first demonstrated by Cuccia and a team at the Beckman Laser Institute (BLI) in 2005, is intended to allow the effects of scattering and absorption to be separated when imaging a biological specimen. The technique works by shining different patterns of light on the tissue, recording a video of the remitted light, and processing the visual information acquired.

In its basic implementation, the target tissue is illuminated with various frequency modulations of a periodically repeating pattern, and the diffuse reflectance at multiple spatial frequencies is detected. Mathematical models can then reconstruct the absorption and scattering coefficients of the tissue, ultimately yielding quantitative spatial maps of the tissue's optical properties and biochemical composition.

Aside from Cuccia, the Modulated Imaging board includes Bruce Tromberg, director of the BLI at the University of California, Irvine.

"Unlike other optical imaging devices used for assessing tissue, Clarifi quantifies and displays hemoglobin concentration and distribution in the superficial and subsurface layers," said Tromberg. "It is a powerful example of how cutting edge optical imaging and computational technologies can be combined to create new, accessible tools for precision medicine."

Modulated Imaging is currently ramping up production of the Clarifi imaging system and expects to start fulfilling orders by the end of the fourth quarter of 2018.