GE医疗6月5日宣布，Invenia ABUS乳腺成像技术获FDA批准。在临床试验中，该设备能够比单独乳房X光检查出更多（超过35.7%）的癌症。首批Invenia ABUS设备安装将在美国弗吉尼亚州和菲尔普斯纪念医院。GE医疗将在2014年下半年陆续向美国各地的医疗服务提供者推出该设备。
英文原文：GE Healthcare Nabs FDA Approval of Invenia ABUS Breast Imaging Technology
GE Healthcare said Monday it is launching the Invenia ABUS breast imaging technology in the U.S., following receipt of FDA approval. Clinical studies showed the device was capable of finding 35.7 percent more cancers in women with dense breasts than mammogram alone.
The first Invenia ABUS installations will be at Fairfax Radiological Consultants in Virginia and Phelps Memorial Hospital in Westchester, N.Y. The technology will continue to roll out to healthcare providers across the country through the remainder of the year, GE says.
The U.K-based company is the sole provider of FDA-approved automated breast ultrasound screening in the U.S. market, Anders Wold, president and CEO of GE Healthcare's ultrasound business, tells Device Daily Bulletin.
According to Wold, the Invenia ABUS offers distinct advantages over other technologies, including:
No-dose screening, so there is no radiation risk to the patient;
Patented Reverse Curve transducer technology, which conforms to a woman’s anatomy, offering enhanced patient comfort;
A new Compression Assist technology, which applies light compression automatically to the breast for increased ease and image reproducibility without physician contact; and
3D ultrasound technology that comfortably and quickly images women with dense breast tissue in as little as 15 minutes.
The launch comes at a time when there is increased awareness of the higher risk of cancer for women with dense breast tissue. A woman with denser breasts is four to six times more likely to develop breast cancer than a woman with less dense breasts, the company says.
GE Healthcare plans to commercialize the technology in other counties in the coming year, Wold said. — Kellen Owings.