Modulated Imaging receives US FDA clearance for Ox-Imager CS system

Modulated Imaging Ox-Imager

Modulated Imaging has received clearance from the US Food and Drug Administration (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 authorisation, Modulated Imaging can now launch the technology at clinical centres throughout the USA.

The Ox-Imager CS system measures oxy-haemoglobin (HbO2), deoxy-haemoglobin (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 colour photograph.

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

The subject of over 50 published scientific articles, the Ox-Imager CS non-contact, light-based imaging system possesses a wide field of measurement (15cm x 20cm). Images take approximately 10 seconds to produce.

Anand S Patel, chief of Interventional Radiology at Providence Little Company of Mary Medical Center, Torrance, USA, says, “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.”