最新技术

GE医疗无射线Invenia ABUS乳腺成像技术获FDA批准

发布时间:2018-07-18 

       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。
       GE医疗总部位于英国,在美国市场中,该公司是FDA批准的自动化乳腺超声检查设备的唯一供应商。
与其他技术相比,Invenia ABUS具有明显的优势,包括:

  • 无计量筛查,所以对患者没有辐射风险;
  • 利性反向曲线传感器技术,符合女性乳房的解剖结构,可提供增强色舒适度;
  • 一种新的压迫辅助技术,会自动将光压迫至乳房,无需医师帮助便可获得易用性增强和可重复性图像。
  • 3D超声技术,能够在短短的15分钟时间内,舒适且快速对女性致密乳腺组织成像。

       目前,已逐渐意识到致密乳腺组织与癌症高风险相关。乳腺组织更致密的女性群体,与乳腺组织不那么致密的女性群体相比,罹患乳腺癌的风险增加4-6倍。
       GE医疗计划在未来一年内,在其他国家推出该设备。
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.
 

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