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Breast Cancer

Breast cancer: GE Healthcare wins pivotal FDA approval for 3D breast imaging

September 2, 2014 By Arezu Sarvestani

GE Healthcare wins pivotal FDA approval for 3D breast tomosynthesis

Imaging giant GE Healthcare (NYSE:GE) won FDA approval for its 3D breast tomosynthesis imaging system, MassDevice.com has learned.

Filed Under: Imaging, News Well, Pre-Market Approval (PMA) Tagged With: Breast Cancer, GE Healthcare

Press Release: Siemens files PMA for digital breast tomosynthesis

June 27, 2014 By Arezu Sarvestani Leave a Comment

Press Release: Siemens files PMA for digital breast tomosynthesis

MALVERN, Pa. — Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT Inspiration® with Breast Tomosynthesis option.

Filed Under: Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Women's Health Tagged With: Breast Cancer, Press Release, Siemens

Siemens seeks FDA approval for next-gen mammograms with tomosynthesis

June 27, 2014 By Arezu Sarvestani Leave a Comment

Siemens seeks FDA approval for 3D mammograms

Healthcare giant Siemens (NYSE:SI) this week filed its premarket approval application to get the FDA’s OK to add a tomosynthesis option to its Mammomat Inspiration mammography system.

Filed Under: Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Women's Health Tagged With: Breast Cancer, Siemens

Dune Medical secures $14M for breast cancer detection

June 26, 2014 By Arezu Sarvestani Leave a Comment

Dune Medical secures $21M for breast cancer detection

Israeli imaging systems maker Dune Medical Devices touted the successful raise of $14 million in equity financing, looking to secure another $7 million before October to support its commercialization efforts.

Filed Under: Funding Roundup, News Well Tagged With: Breast Cancer, Dune Medical Devices Inc.

Press Release: VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection (CAD) for Mammography Version 3.1

June 11, 2014 By MassDevice Leave a Comment

Press Release: VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection (CAD) for Mammography Version 3.1

Filed Under: Food & Drug Administration (FDA), Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Women's Health Tagged With: Breast Cancer, Press Release, VuComp Inc.

VuCOMP lands FDA nod for updated M-Vu mammography system

June 11, 2014 By Arezu Sarvestani Leave a Comment

VuCOMP lands FDA nod for updated M-Vu mammography system

Cancer detections systems maker VuCOMP announced this week that it won FDA approval for new computer-aided detection software, launching version 3.1 of its M-Vu CAD for mammography.

Filed Under: Food & Drug Administration (FDA), Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Women's Health Tagged With: Breast Cancer, VuComp Inc.

Press Release: GE Healthcare Announces FDA Approval of Invenia Automated Breast Ultrasound System

June 4, 2014 By MassDevice

Press Release: GE Healthcare Announces FDA Approval of Invenia Automated Breast Ultrasound System

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Ultrasound, Women's Health Tagged With: Breast Cancer, GE Healthcare, Press Release

GE Healthcare wins FDA approval for dense-breast mammograms

June 4, 2014 By Arezu Sarvestani Leave a Comment

GE Healthcare wins FDA approval for dense-breast mammograms

GE Healthcare (NYSE:GE) announced this week that it won FDA approval for its Invenia Automated Breast Ultrasound system, indicated to help doctors identify cancers in women with dense breast tissue.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Ultrasound, Women's Health Tagged With: Breast Cancer, GE Healthcare

Study: Most women getting double mastectomies don’t need them | MassDevice.com On Call

May 22, 2014 By Arezu Sarvestani Leave a Comment

MassDevice.com On Call

MASSDEVICE ON CALL — The majority of women who’ve had both breasts removed following a breast cancer diagnosis probably didn’t need to take such drastic measures, according to a new study.

Researchers from the University of Michigan Comprehensive Cancer Center reported that as much as 70% of women who opted for a double mastectomy following breast cancer did so despite a very low risk of recurrence.

Filed Under: News Well, Women's Health Tagged With: Breast Cancer, On Call

Breast cancer: Mammograms don’t reduce deaths, researchers say

April 7, 2014 By Arezu Sarvestani Leave a Comment

Breast cancer: Mammograms don't reduce deaths, researchers say

Breast cancer experts are calling for a fresh look at routine mammography, warning that screening may not save lives and may instead lead to risky overdiagnoses.

Filed Under: News Well, Oncology, Women's Health Tagged With: Breast Cancer, Clinical Trials

Hologic eyes reimbursement win for breast tomosynthesis

March 6, 2014 By Arezu Sarvestani Leave a Comment

Hologic eyes reimbursement win for breast tomosynthesis

Massachusetts medical device maker Hologic’s (NSDQ:HOLX) is eying a potential Medicare reimbursement win for its breast tomosynthesis systems after landing an early milestone.

Filed Under: Mammography, Medicare, News Well, Women's Health Tagged With: American Medical Assn., Breast Cancer, Hologic, Insurance

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