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Omega Medical Imaging, Inc.
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The U.S. Food and Drug Administration (FDA) granted Omega Medical Imaging 510(k) clearance to offer their artificial intelligence (AI)-powered region of interest (ROI) radiation exposure reduction solution FluoroShield for interventional X-ray imaging on their flat panel detector CS-series product lines.
Angiographic imaging system vendors have developed several new technologies to address emerging cath lab trends, including the need to reduce radiation dose, improve image quality and enable advanced procedural image guidance. All three of these points have become increasingly important as more complex procedures are attempted in interventional labs and hybrid ORs. These procedures include embolic coiling, neuro-interventions, thrombectomy, aortic repair, transcatheter aortic valve replacement (TAVR), mitral clip valve repairs, left atrial appendage (LAA) occlusions, atrial and ventricular septal defect closures, and new interventions for both electrophysiology (EP) and heart failure.