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Mammography

SmartBreast, FITI partner for molecular breast imaging system manufacturing

February 9, 2021 By Danielle Kirsh

SmartBreast today announced it has forged a partnership with FoxSemicon Integrated Technologies (FITI) to manufacture molecular breast imaging systems. FITI will be the contract manufacturer of the two molecular breast imaging systems recently acquired by SmartBreast, the GE Healthcare Discovery NM750b and the Dilon Technologies D6800. SmartBreast previously announced that it would be rebranding the […]

Filed Under: Business/Financial News, Imaging, Mammography Tagged With: FoxSemicon Integrated Technologies, SmartBreast

GE Healthcare sells molecular breast imaging assets to SmartBreast

February 8, 2021 By Danielle Kirsh

SmartBreast today announced that it has acquired GE Healthcare (NYSE:GE)’s molecular breast imaging assets for an undisclosed amount. The Pittsburgh-based company acquired the Discovery NM750b and other MBI scanner designs, manufacturing tools, instructions and related patents and installed-base service business as part of the deal. SmartBreast will begin to market and distribute the Discovery NM750b and […]

Filed Under: Diagnostics, Imaging, Mammography, Women's Health Tagged With: GE Healthcare, SmartBreast

GE Healthcare debuts breast cancer tech

October 20, 2020 By Sean Whooley

GE Healthcare (NYSE:GE) announced today that it made the Serena Bright biopsy technology available in the U.S. Chicago-based GE Healthcare touts Serena Bright as the industry’s first contrast-enhanced guided biopsy solution, according to a news release. The technology is designed to help clinicians and patients in the fight against breast cancer. Serena Bright received FDA 510(k) […]

Filed Under: Business/Financial News, Featured, Imaging, Mammography, Oncology, Women's Health Tagged With: GE Healthcare

FDA clears Zebra Medical’s AI tool for mammograms

July 28, 2020 By Sean Whooley

Zebra Medical Vision announced that it received FDA 510(k) clearance for its HealthMammo mammography algorithm technology. Shefayim, Israel-based Zebra Medical Vision develops the system, which already has CE Mark approval, to allow breast radiologists to prioritize and identify suspicious mammograms, providing a safety net for radiologists and offering faster reads on mammograms than the current […]

Filed Under: 510(k), Food & Drug Administration (FDA), Health Technology, Imaging, Mammography, Oncology, Regulatory/Compliance, Software / IT Tagged With: FDA, Zebra Medical Vision

Hologic launches first cart-based ultrasound system in U.S.

July 8, 2020 By Sean Whooley

Hologic (NSDQ:HOLX) announced today that it launched its SuperSonic MACH 40 premium, cart-based ultrasound system in the U.S. The Marlborough, Mass.-based company touts the SuperSonic platform as its first cart-based system, saying in a news release that the new system features strong image quality, standard-setting imaging modes and design to enhance efficiency and accuracy. SuperSonic uses […]

Filed Under: Business/Financial News, Imaging, Mammography, Ultrasound Tagged With: Hologic

Lunit wins CE Mark for AI-based breast cancer detection software

June 2, 2020 By Sean Whooley

Lunit announced today that it received CE Mark approval in Europe for its Lunit Insight MMG artificial intelligence-based software. Insight MMG uses AI to analyze mammography images and provide the location of lesions that are suspicious for breast cancer, along with an abnormality score that reflects the probability of the existence of detected lesions. According […]

Filed Under: Health Technology, Imaging, Mammography, Oncology, Regulatory/Compliance, Software / IT Tagged With: CE Mark, Lunit

iCad raises $12.5m

April 28, 2020 By Sean Whooley

iCad (NSDQ:ICAD) announced that it entered into agreements for the purchase and sale of its common stock for gross proceeds of approximately $12.5 million. The agreements included the sale of more than 1.5 million shares of Nashua, N.H.-based iCad’s common stock at $8 per share. Craig-Hallum Capital Group is acting as financial advisor in connection with […]

Filed Under: Business/Financial News, Funding Roundup, Imaging, Mammography Tagged With: iCad Inc.

Hologic Q1 results are a mixed bag

January 29, 2020 By Chris Newmarker

Hologic (NSDQ:HOLX) posted first quarter results this evening that either matched or beat the consensus forecast on Wall Street, upping its earnings forecast for the year while cutting its projected revenue range. The Marlborough, Mass.–based women’s health medtech company reported profits of $385.8 million, or $1.43 per share, on sales of $850.5 million for the three […]

Filed Under: Business/Financial News, Featured, Gynecological, Imaging, Mammography, Wall Street Beat, Women's Health Tagged With: Hologic

FDA reclassifies some medical image analyzers

January 21, 2020 By Nancy Crotti

The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II. Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any […]

Filed Under: Featured, Imaging, Mammography, Radiosurgery/Radiation therapy, Ultrasound Tagged With: FDA

Bayer wins FDA clearance for expanded CT injection system

December 23, 2019 By Danielle Kirsh

Bayer received FDA 510(k) clearance for expanded use of its Medrad Stellant Flex CT injection system with Certegra Workstation. The system is cleared for use in contrast-enhanced mammography (CEM), which can allow for better visualization fo abnormalities in breast tissue that may not be visible in standard mammography. “This FDA clearance underscores Bayer’s continued commitment […]

Filed Under: 510(k), Mammography Tagged With: Bayer

Could an algorithm improve breast cancer treatment?

December 20, 2019 By Sean Whooley

A study from researchers at Penn Medicine revealed that MRI and an algorithm-based field of medicine called radiomics could help characterize the heterogeneity of cancer cells in a tumor and allow for better understanding of the causes and progression of individual diseases. The study, published in Clinical Cancer Research, examines radiomics, which uses algorithms to extract […]

Filed Under: Clinical Trials, Featured, Imaging, Mammography, Oncology, Radiosurgery/Radiation therapy, Women's Health Tagged With: Breast Cancer, University of Pennsylvania

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