Modulated Imaging has obtained approval from the US Food and Drug Administration (FDA) for its Ox-Imager CS system.
The company has designed the device to enable clinicians to identify lower limb vascular issues in patients for providing effective and timely treatment.
The Ox-Imager CS system will measure oxy-hemoglobin (HbO2), deoxy-hemoglobin (HbR) and tissue oxygen saturation (StO2) in individuals with compromised circulation.
It provides better information on these indicators of tissue health, as well as captures digital color photograph.
The non-invasive Ox-Imager CS system is claimed to be the only technology that will offer both surface and subsurface views in one comprehensive system.
Through aggregating the firm’s SFDI technology with broadband imaging in the visible and near-infrared light ranges, the system will allow clinicians to capture comprehensive view of tissue perfusion with a single device.
Modulated Imaging CEO Dr David Cuccia said: “This FDA clearance is a major milestone for our company, and for the patients and physicians within the vascular treatment communities.
“We’re proud to be able to provide meaningful information that advances patients’ health and wellness.”
Providence Little Company of Mary Medical Center interventional radiology chief Dr Anand Patel said: “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.
Modulated Imaging is engaged in the development of light based imaging technology to prevent, diagnose and cure medical conditions.