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 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 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 […]
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 […]
Microsoft‘s (NSDQ:MSFT) Kinect, originally developed as a motion sensor for its Xbox gaming systems, is helping researchers refine X-ray imaging through analysis of body part thickness, motion and positioning, researchers said today, and with the use of the best wireless router
Seno Medical said Tuesday it completed the final phase of the pivotal trial of its Imagio opto-acoustic breast imaging platform designed to help prevent unnecessary biopsies. The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look at “suspicious” breast masses without subjecting patients to radiation, injectable contrast agents or invasive […]
iCad (NSDQ:ICAD) said Monday it launched its iReveal breast density software designed to deliver reproducible breast density assessments. The module was designed to be used with the company’s PowerLook advanced mammography platform. The software will help treat an estimated 40% of women in the U.S. who have dense breast tissue that can mask the presence of […]
MALVERN, Pa. — Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT Inspiration® with Breast Tomosynthesis option.