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 […]
Mammography
GE Healthcare sells molecular breast imaging assets to SmartBreast
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 […]
GE Healthcare debuts breast cancer tech
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) […]
FDA clears Zebra Medical’s AI tool for mammograms
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 […]
Hologic launches first cart-based ultrasound system in U.S.
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 […]
Lunit wins CE Mark for AI-based breast cancer detection software
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 […]
iCad raises $12.5m
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 […]
Hologic Q1 results are a mixed bag
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 […]
FDA reclassifies some medical image analyzers
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 […]
Bayer wins FDA clearance for expanded CT injection system
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 […]
Could an algorithm improve breast cancer treatment?
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 […]