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 […]
Hologic wins CE mark approval for implantable tag
Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer radiofrequency identification (RFID) tag for long-term placement. Under yesterday’s extension approval, the LOCalizer can now be implanted more than 30 days prior to a breast-conserving surgery to improve flexibility and convenience for both patients and providers. The LOCalizer is a […]
Hologic wins FDA approval for 3DQuorum AI imaging technology
Hologic today said it received FDA approval for its 3DQuorum Imaging Technology that is powered by the company’s Genius AI. The imaging technology works with Hologic’s Clarity HD high-resolution imaging technology to reduce tomosynthesis image volume for radiologists. Using Genius AI-powered analytics, 3DQuorum reconstructs high-resolution 3D data to make 6mm “SmartSlices.” The analytics help doctors […]
Report: Imaging industry put $9m into pushing 3D mammograms despite lack of evidence
Companies that make 3D mammography equipment have spent millions on marketing the devices, even though scientific evidence of their superiority to traditional mammography is lacking, according to a new report. The report by Kaiser Health News says that Hologic (NSDQ:HOLX), GE Healthcare (NYSE:GE), Siemens Healthineers and Fujifilm (TSE:4901) have paid doctors and teaching hospitals a collective $9.2 […]
iCad’s AI-assisted mammography tech wins CE Mark
iCad (NSDQ:ICAD) has won the CE Mark for its advanced artificial intelligence technology and workflow solution, ProFound AI for 2D mammography. The Nashua, N.H.-based cancer detection and radiation therapy devices maker developed the technology to boost breast cancer detection by identifying soft-tissue densities and calcifications. ProFound AI for 2D mammography is the latest addition to […]
FDA wants to update mammography standards
The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers. The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, […]
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