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GE HEALTHCARE ACQUIRES FDA APPROVAL FOR NEW AUTOMATED 3D BREAST IMAGING SYSTEM INVENIA

Women with dense breasts present a problem for imaging specialists because of the inability to view the breast completely. Using X-Ray mammography, focal breast lesions could potentially be missed because of its lower sensitivity in women with dense breasts. With the new Invenia Automated Breast Ultrasound System (ABUS) from GE, doctors can view the anatomic coronal plane in three dimensions. This new-generation technological innovation gives doctors the ability to find pathological lesions sooner, and take a needed course of action.

The Invenia system is patient-friendly, with a new Reverse curve transducer that conforms to a woman’s natural anatomy.  It also has new features like Compression Assist which exerts a small force on the breast guaranteeing a firm seal.  In addition, all of the automated tools offered in the Invenia ABUS system make standardized imaging possible.

In the FDA clinical trials, the Invenia system was shown to identify 35.7% more breast cancers in women with dense breasts than X-Ray mammography [1].

1. FDA PMA P110006 summary of safety and effectiveness.

2. Boyd NF et al. Mammographic Density and the Risk and Detection of Breast Cancer. NEJM 2007; 356: 227-36. Boyd, et al, NEJM Jan 2007.

http://www.youtube.com/watch?v=xGk-0JXnPiQ

11.09.2014

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