iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new […]
Mammography
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]
SmartBreast, FITI partner for molecular breast imaging system manufacturing
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 […]
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 […]
