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GE Healthcare
New Clinical Indication

New Clinical Indication

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Condition:   New
GE Healthcare’s VolumeRAD* Tomosynthesis is an established, broad indication technology utilized by radiologists for years.
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Advanced Applications: New Clinical Indication GE Healthcare’s VolumeRAD* Tomosynthesis is an established, broad indication technology utilized by radiologists for years. A recent international multicenter clinical trial has demonstrated that VolumeRAD imaging of the chest offers improved detection and management of patients with lung nodules compared to conventional radiography. Detection Improvement: VolumeRAD significantly increases detection sensitivity, enabling the radiologist to confidently detect more lung nodules than 2-view chest X-ray (CXR). Patient Management: Radiologists are significantly more accurate at correctly identifying cases requiring follow-up with VolumeRAD than with 2-view chest X-ray. Dose Reduction: With a VolumeRAD Tomosynthesis exam, including a standard PA image, patients receive only 1.6 times more radiation than they do with a two-view (PA and LAT) chest X-ray exam. No clinical evidence has been established supporting the following claims in patients with active lung or pleural disease that could obscure pulmonary nodules, including fibrosis, emphysema, compressed lung, scarring, severe lung disease, and in patients with objects in or around the lungs that could obscure pulmonary nodules. The effectiveness of the device may vary depending on nodule prevalence and type.