Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy.
The blended image incorporates a lower frequency refresh of the peripheral image area. This combined image (live fluoroscopy or cine of ROI + background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures.
According to the press release, the benefits of FluoroShield include:
- Image quality is improved via auto-collimation resulting in a reduced field of view and subsequently less exposure to harmful X-ray
- Anatomical landmarks and devices visible outside the region of interest provide important clinical information which are viewed at a reduced exposure level/rate
- Fluoroshield can be sized and positioned in manual mode, as opposed to conventional collimation, which is generally limited to positioning about the centre of the image
- Auto ROI automatically follows the movement of devices (i.e., catheters, etc.), minimising distraction and input requirements for the operator.
Brian Fleming, president of Omega Medical Imaging states: “Until now products on the market have only been able to manage radiation to patients and staff. FluoroShield is the only system in the world that provides an actual reduction in dose. The impact of this ground-breaking solution for patients and healthcare providers is substantial. I am very grateful to be a part of a team that pushes the envelope in the development of safer healthcare solutions.”