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, […]
Fujifilm levels mammography patent infringement, anti-trust claims against Hologic
Fujifilm Holdings (TSE:4901) last week accused mammography rival Hologic (NSDQ:HOLX) of patent infringement and unfair trade practices, alleging that Hologic aimed to unlawfully maintain its 80% share in the 3D mammography market. The Japanese tech firm claims in the suit that its Aspire Cristalle system, which sells for roughly half the average $452,000 price of Hologic’s competing […]
The 11 most innovative medical devices of 2017
The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
Hologic files infringement suit against Fujifilm Medical over mammogram tech
Fujifilm Holdings (TSE:4901) subsidiary Fujifilm Medical Systems is facing a patent infringement suit from Hologic (NSDQ:HOLX), which claims that the company infringed on 5 of its mammogram technology patents, according to a Connecticut Law Tribune report. The suit, filed in the US District Court for the District of Connecticut on Monday claims that Japan-based Fujifilm “had specific […]
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