FDA Clearance Received for Ox-Imager CS System

Modulated Imaging, Inc. announced today that it has received clearance from the FDA for its Ox-Imager CS technology. This device is designed to assist clinicians with the identification of lower limb vascular issues, so that patients can receive appropriate, timely treatment. With FDA authorization, Modulated Imaging can now launch the technology at clinical centers throughout the United States.

The Ox-Imager CS system measures oxy-hemoglobin (HbO2), deoxy-hemoglobin (HbR) and tissue oxygen saturation (StO2) in individuals with compromised circulation. The device reports on these important indicators of tissue health, and also displays a digital color photograph.

The non-invasive Ox-Imager CS system is the only technology to provide both surface and subsurface views in one comprehensive system. By combining Modulated Imaging’s groundbreaking SFDI technology with broadband imaging in the visible and near-infrared light ranges, Ox-Imager CS enables clinicians to acquire a comprehensive view of tissue perfusion with a single device.

The subject of over 50 published scientific articles, Ox-Imager CS addresses the shortcomings of existing technologies with a non-contact, light-based imaging system possessing a wide field of measurement (15cm x 20cm). Images take only 10 seconds to produce. These advantages can lead to early intervention in lower limb vascular issues.

“Ox-Imager is a great example of how precision medicine could help the medical community provide the best possible treatment in the most timely manner for each patient’s needs,” said Anand S. Patel, MD, Chief of Interventional Radiology at Providence Little Company of Mary Medical Center. “Modulated Imaging’s technology has great potential to enable us to better diagnose patients with compromised circulation who may be at risk for lower limb diabetic complications, peripheral arterial disease, and similar conditions.”

“This FDA clearance is a major milestone for our company, and for the patients and physicians within the vascular treatment communities,” said David Cuccia, PhD, Modulated Imaging’s CEO and CTO. “Ox-Imager can lead to significant preventive care actions as well as an estimated potential of $6.2 billion in savings per year. We’re proud to be able to provide meaningful information that advances patients’ health and wellness.”

Modulated Imaging, Inc. was founded in 2008 to develop light based imaging technology for preventing, diagnosing, and curing medical conditions. The company’s innovative science is designed to profoundly increase quality-of-life. Learn more at www.modulatedimaging.com.